A Clinical Evaluation of the Eclipse™ System, a Vaginal Bowel Control (VBC) Therapy for Fecal Incontinence in Women
Phase: NA
Conditions: Fecal Incontinence
Sponsor: Pelvalon, Inc.

 
 
 
 
Clinical Investigational Plan 
 
LIBERATE:  
A Clinical Evaluation of the Eclipse™ System, a Vaginal 
Bowel Control (VBC) Therapy for Fecal Incontinence in 
Women  
 
Protocol: CA005 
Revision: D 
Date:  09 Feb 2017 
 
 
 
 
 
 
 
 
Study Sponsor: 
Pelvalon, Inc. 
923 Thompson Place 
Sunnyvale, CA 94085 
 
 
 
 
 
CONFIDENTIAL - THIS DOCUMENT CONTAINS CONFIDENTIAL AND PROPRIETARY INFORMATION THAT IS THE 
PROPERTY OF PELVALON, INC. NEITHER THIS DOCUMENT NOR THE INFORMATION HEREIN MAY BE REPRODUCED, 
USED, OR DISCLOSED TO ANY THIRD PARTY WITHOUT THE PRIOR WRITTEN CONSENT OF PELVALON, INC. 
 
Page 1 of 58 
 

 
 
 
 
LIBERATE Protocol Synopsis 
Study 
Objective 
To evaluate the durability of the safety and effectiveness of the Eclipse™ System after 
3 and 12 months of use.  
Study 
Design 
Multi-center, prospective, within-subject control, open label clinical trial 
Sites/ 
Subjects 
Up to 150 treatment-eligible subjects may be enrolled into the 12 month Treatment 
Period at up to 15 clinical sites in the United States 
Study 
Population 
Adult females diagnosed with fecal incontinence (FI) 
Study 
Duration  
Screening Period: 5 - 7 weeks*  
Treatment Period: 12 months 
* Screening may be extended by up to an additional 6 weeks to allow for estrogen pre-
treatment, if required 
Primary 
Endpoint 
The proportion of treatment responders, defined as a ≥ 50% reduction in the average 
number of FI episodes per week, as compared to baseline, at the 3 month time point 
in the ITT population  
Secondary 
Endpoints 
 
1. Proportion of treatment responders at the 3, 6 and 12 month time points in the per 
protocol (PP) population 
2. Change from baseline in mean scores on subject-reported outcomes related to 
symptoms and quality of life as reported by St. Mark’s (Vaizey) Incontinence 
Severity Score, and FI Quality of Life (FIQOL) 
3. Patient Global Impression of Improvement (PGI-I) scores at the 3, 6, 9 and 12 
month time points 
Safety 
Endpoint 
Safety of the Eclipse System is assessed by the number of device-related (Eclipse 
System) adverse events, and device-related serious adverse events. 
Subgroup 
Analyses 
< 65 years of age versus ≥ 65 years of age 
Inclusions:
General 
Eligibility 
Criteria 
1. Female sex 
2. Age 19 years or older  
3. History of FI for at least 6 months 
4. Subject willing and able to give written informed consent to participate in the study  
5. Subject can read, write and communicate fluently in English (the study diaries, 
questionnaires and instructions are only provided in English) 
6. Subject willing and able to comply with visit schedule 
7. Subject is able to physically manage the insertion and removal of the Insert1 
Exclusions: 
Pregnancy 
Exclusion 
Criteria 
8. Vaginal childbirth within the last 18 months  
9. Currently pregnant or planning pregnancy during the study period 
10. A positive pregnancy test or, if at risk of pregnancy (i.e. of childbearing potential), 
does not have a documented method of birth control. 
Exclusions: 
Physical / 
Pelvic 
Exam 
Criteria 
 
11. Presence of fecal impaction on pelvic exam 2 
12. Presence of an open wound or tear in the vagina or anus on pelvic exam 2 
13. Atrophic vaginal tissue that would inhibit the comfortable wearing of a vaginal 
insert, as determined by symptoms or visualization on pelvic exam 2 
14. Current vaginal infection requiring treatment on pelvic exam 2 
15. Current urinary tract infection requiring treatment 3 
CONFIDENTIAL - THIS DOCUMENT CONTAINS CONFIDENTIAL AND PROPRIETARY INFORMATION THAT IS THE 
PROPERTY OF PELVALON, INC. NEITHER THIS DOCUMENT NOR THE INFORMATION HEREIN MAY BE REPRODUCED, 
USED, OR DISCLOSED TO ANY THIRD PARTY WITHOUT THE PRIOR WRITTEN CONSENT OF PELVALON, INC. 
 
Page 2 of 58 
 

 
 
 
 
Exclusions: 
Current / 
Prior FI 
Treatments 
 
16. Supervised anal sphincter exercises/pelvic floor muscle training with or without 
biofeedback within the last 3 months and unwillingness to abstain from such for 
duration of study participation 
17. Use of home e-stim devices to stimulate pelvic floor muscles and unwillingness to 
abstain from such use for duration of study participation 
18. Percutaneous Tibial Nerve Stimulation (PTNS) treatment within the last 3 months 
and unwillingness to abstain from such for duration of study participation 
19. Injectable bulking agents (e.g. Solesta®) for treatment of FI within the last 3 
months and unwillingness to abstain from such for duration of study participation 
20. Current sacral nerve stimulator (SNS) implant (Interstim®) used within the last 3 
months. If SNS unit is implanted, there must be documented evidence that the 
device has been turned "off" for the past 3 months and the patient must agree to 
abstain from use for duration of study 
21. Presence of an artificial bowel sphincter implant 
22. Active participation in another bowel or pelvic floor disorder investigational study, if 
the treatment could affect use of the Eclipse System, its safety or effectiveness, or 
otherwise confound the results of this study 
Exclusions: 
Prior 
Surgeries 
 
23. History of surgical diversion or removal of any portion of the bowel, except 
appendectomy or cholecystectomy 
24. History of bariatric surgery  
25. Hysterectomy within the last 6 months 
26. Native tissue repair for pelvic organ prolapse within past 6 months 
27. Any history of reconstructive mesh surgery for pelvic organ prolapse or FI (mesh 
mid urethral slings are allowed) 
28. Urinary incontinence surgical procedure within past 6 months 
29. Colorectal/anal surgery such as rectopexy, sphincteroplasty, graciloplasty within 
the last 12 months 
Exclusions: 
Concurrent 
Medical 
Conditions 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
30. Chronic (greater than 6 months) abdominal pain in the absence of diarrhea 
31. Inflammatory bowel disease (IBD) such as Crohn’s Disease or Ulcerative Colitis 
32. Grade III or IV hemorrhoids 
33. Congenital anorectal malformation 
34. Chronic watery diarrhea (3 or more loose stools per day for 4 weeks or more) 
unmanageable by drugs or diet as primary cause of FI per review of subject 
history and baseline diary  
35. Laxative use as primary cause of FI 
36. Chronic (greater than 3 months) fecal impaction requiring ongoing treatment  
37. Rectal prolapse (mucosal or full thickness) 
38. Chronic (greater than 6 months) rectal, anal or pelvic pain 
39. History of chronic or recurrent UTIs (2 or more positive cultures within the last 6 
months or 3 or more positive cultures within the last year)  
40. History of chronic or recurrent vaginal infections (4 or more per year) within the 
past year 
41. Any pelvic organ prolapse that extends beyond the plane of the hymen  
42. Concurrent use of an intra-vaginal pessary or other device that would interfere 
with the Eclipse™ Insert placement or wearing 
43. Presence of any urogenital or colorectal fistula involving the vagina, history of a 
recurrent fistula, or history of a prior failed or complicated fistula repair. A remote 
history (≥12 months) of a single, well-healed fistula repair is allowed.   
44. Anal or pelvic (colorectal or genitourinary) malignancy within past five years 
45. History of pelvic irradiation for cancer 
46. Life expectancy of less than three years 
 
 
CONFIDENTIAL - THIS DOCUMENT CONTAINS CONFIDENTIAL AND PROPRIETARY INFORMATION THAT IS THE 
PROPERTY OF PELVALON, INC. NEITHER THIS DOCUMENT NOR THE INFORMATION HEREIN MAY BE REPRODUCED, 
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Exclusions: 
Concurrent 
Medical 
Conditions 
(cont.) 
 
47. Uncontrolled and complicated autoimmune or inflammatory disorder such as 
Systemic Lupus Erythematosus, Sjogren’s Syndrome, Rheumatoid Arthritis, or 
AIDS, that could have a confounding effect on FI severity or frequency during a 
yearlong study participation 
48. Neurological disorders known to affect bowel continence, such as advanced 
Multiple Sclerosis or Parkinson’s disease 
49. Subject has an unstable condition (e.g. psychiatric disorder, recent history of 
substance abuse) or otherwise thought to be unreliable or incapable of complying 
with the requirements of the study protocol   
50. Any other significant medical condition or lifestyle factor or confounder that the 
investigator believes would interfere with study participation and/or increase 
subject risk or interpretation of the primary or secondary endpoints 
Inclusions: 
Baseline 
Diary 
51. At least 4 episodes of FI recorded during the 2-week Baseline Diary 1 
52. At least 12 out of 14 consecutive days of diary data recorded on the Baseline 
Diary1 
Inclusions: 
Device 
Fitting 
53. Successful fitting of the Trial Insert, i.e. device is both stable and comfortable 
while wearing 1 
54. Subject is able to physically manage the insertion and removal of the Insert 1 
Inclusions: 
Test Diary 
 
55. Subject attains a 50% reduction or more in the number of FI episodes while 
wearing the Trial Insert in the 2-week Fitting Period compared to their 2-week 
Baseline Period. 1  
56. At least 12 out of 14 consecutive days of diary data recorded on the Test Diary 1 
1   These criteria will be assessed at the appropriate follow-up visit. 
2     Subjects may be treated and re-assessed to qualify for study participation. 
3     Subjects should be treated as clinically indicated and may complete their baseline diary, but they must 
have a documented negative urine dipstick or urine culture test prior to the Initial Fitting at visit 2. 
CONFIDENTIAL - THIS DOCUMENT CONTAINS CONFIDENTIAL AND PROPRIETARY INFORMATION THAT IS THE 
PROPERTY OF PELVALON, INC. NEITHER THIS DOCUMENT NOR THE INFORMATION HEREIN MAY BE REPRODUCED, 
USED, OR DISCLOSED TO ANY THIRD PARTY WITHOUT THE PRIOR WRITTEN CONSENT OF PELVALON, INC. 
 
Page 4 of 58 
 

 
 
 
 
Table of Contents 
 
1 
Background ..................................................................................................................................... 7 
1.1 
Epidemiology of FI .............................................................................................................................................................. 7 
1.2 
Causes of FI ........................................................................................................................................................................ 7 
1.3 
Available Treatments........................................................................................................................................................... 7 
1.4 
Description of the Eclipse System ....................................................................................................................................... 8 
1.4.1 
Overview ...............................................................................................................................................................................................8 
1.4.2 
The Sizing Kit ........................................................................................................................................................................................8 
1.4.3 
The Trial Insert ......................................................................................................................................................................................8 
1.4.4 
The Eclipse Insert .................................................................................................................................................................................8 
1.4.5 
The Pump ..............................................................................................................................................................................................9 
1.5 
Mechanism of Action of the Eclipse System ........................................................................................................................ 9 
1.6 
Prior Investigations ............................................................................................................................................................ 11 
1.6.1 
Feasibility Studies .............................................................................................................................................................................. 11 
1.6.2 
LIFE Pivotal Study .............................................................................................................................................................................. 11 
1.7 
Rationale for this Trial ....................................................................................................................................................... 12 
1.8 
Regulatory Status of the Eclipse System ........................................................................................................................... 12 
1.9 
Indications for Use ............................................................................................................................................................ 12 
2 
Study Description ......................................................................................................................... 12 
2.1 
Design............................................................................................................................................................................... 12 
2.2 
Target Population .............................................................................................................................................................. 12 
2.3 
Recruitment ....................................................................................................................................................................... 15 
2.4 
Schedule of Events ........................................................................................................................................................... 15 
2.5 
Visit Schedule ................................................................................................................................................................... 16 
2.6 
Screening Period ............................................................................................................................................................... 16 
2.6.1 
Pre-Screening .................................................................................................................................................................................... 16 
2.6.2 
Visit 1 - Baseline Visit ......................................................................................................................................................................... 16 
2.6.3 
Visit 2 - Initial Fitting Visit - 14 days (-2/+7 days) from Baseline Visit ............................................................................................... 18 
2.6.4 
Telephone Contact (After Initial Fitting Visit) ..................................................................................................................................... 19 
2.6.5 
Visit 2a / 2b – Repeat Fitting Visits (Optional) – 7 days (-5/+7 days) from the Initial Fitting Visit ..................................................... 19 
2.6.6 
Telephone Contact (After Repeat Fitting Visits) ................................................................................................................................ 20 
2.6.7 
Visit 3 - Fit Confirmation Visit - 7 days (-5/+7days) from the final Fitting Visit .................................................................................. 20 
2.6.8 
Visit 4 – Treatment Eligibility Visit - 14 days (-2/+7 days) after Visit 3 .............................................................................................. 21 
2.7 
Treatment Period .............................................................................................................................................................. 22 
2.7.1 
Telephone Contacts (Between Visit 4 and Visit 5) ............................................................................................................................ 22 
2.7.2 
Visit 5 – 3 Months (± 2 weeks) after Visit 4 ........................................................................................................................................ 23 
2.7.3 
Telephone Contacts (Between Visit 5 and Visit 6) ............................................................................................................................ 23 
2.7.4 
Visit 6 – 6 Months (± 2 weeks) after Visit 4 ........................................................................................................................................ 23 
2.7.5 
Telephone Contacts (Between Visit 6 and Visit 7) ............................................................................................................................ 24 
2.7.6 
Visit 7 – 9 Months (± 2 weeks) after Visit 4 ........................................................................................................................................ 24 
2.7.7 
Telephone Contacts (Between Visit 7 and Visit 8) ............................................................................................................................ 24 
2.7.8 
Visit 8 – 12 Months (± 2 weeks) after Visit 4 ...................................................................................................................................... 24 
2.7.9 
Unscheduled Visits ............................................................................................................................................................................. 25 
2.8 
Re-sizing during Treatment Period .................................................................................................................................... 25 
2.9 
Study Exit .......................................................................................................................................................................... 25 
2.10 
Questionnaires and Surveys ............................................................................................................................................. 26 
2.10.1 
FI Episode Diary ................................................................................................................................................................................. 26 
2.10.2 
St. Mark’s (Vaizey) Incontinence Severity Score ............................................................................................................................... 26 
2.10.3 
Fecal Incontinence Quality of Life Questionnaire .............................................................................................................................. 26 
2.10.4 
PGI-I Questionnaire ........................................................................................................................................................................... 26 
2.10.5 
Patient Goal Questionnaire ................................................................................................................................................................ 27 
2.10.6 
Device Satisfaction Questionnaire ..................................................................................................................................................... 27 
2.10.7 
Cost Utilization Survey ....................................................................................................................................................................... 27 
3 
Statistics ........................................................................................................................................ 27 
3.1 
Study Design ..................................................................................................................................................................... 27 
3.2 
Derivations and Definitions ................................................................................................................................................ 28 
3.3 
Analysis Populations ......................................................................................................................................................... 29 
3.4 
Hypotheses ....................................................................................................................................................................... 29 
3.5 
Endpoints .......................................................................................................................................................................... 29 
3.6 
Primary Effectiveness Analysis.......................................................................................................................................... 29 
3.7 
Secondary Effectiveness Analyses .................................................................................................................................... 30 
3.8 
Additional Analyses ........................................................................................................................................................... 30 
3.9 
Subgroup Analyses ........................................................................................................................................................... 30 
3.10 
Safety Analyses ................................................................................................................................................................ 30 
3.11 
Power and Sample Size Considerations ............................................................................................................................ 30 
4 
Adverse Events ............................................................................................................................. 31 
4.1 
Adverse Event Severity ..................................................................................................................................................... 32 
4.2 
Adverse Event Association ................................................................................................................................................ 32 
4.3 
Adverse Event Reporting .................................................................................................................................................. 32 
CONFIDENTIAL - THIS DOCUMENT CONTAINS CONFIDENTIAL AND PROPRIETARY INFORMATION THAT IS THE 
PROPERTY OF PELVALON, INC. NEITHER THIS DOCUMENT NOR THE INFORMATION HEREIN MAY BE REPRODUCED, 
USED, OR DISCLOSED TO ANY THIRD PARTY WITHOUT THE PRIOR WRITTEN CONSENT OF PELVALON, INC. 
 
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4.3.1 
Adverse Event Coding ....................................................................................................................................................................... 33 
4.3.2 
Clinical Events Committee ................................................................................................................................................................. 33 
4.3.3 
CEC Adjudication of AEs ................................................................................................................................................................... 33 
4.3.4 
SAE Reporting.................................................................................................................................................................................... 33 
4.3.5 
UADE Reporting ................................................................................................................................................................................. 33 
5 
Study Management ....................................................................................................................... 34 
5.1 
Investigational Device Labeling ......................................................................................................................................... 34 
5.2 
IRB Approval ..................................................................................................................................................................... 34 
5.2.1 
Sponsor Statement of Non-significant Risk ....................................................................................................................................... 34 
5.3 
Informed Consent .............................................................................................................................................................. 35 
5.4 
Monitoring ......................................................................................................................................................................... 35 
5.5 
Recordkeeping .................................................................................................................................................................. 36 
5.5.1 
Record Retention ............................................................................................................................................................................... 36 
5.6 
Reports ............................................................................................................................................................................. 36 
5.7 
Additional Investigator Responsibilities .............................................................................................................................. 37 
5.7.1 
Device Storage and Accountability .................................................................................................................................................... 38 
5.7.2 
Product Non-conformities and/or User Feedback ............................................................................................................................. 38 
5.7.3 
Investigator Records .......................................................................................................................................................................... 38 
5.8 
Sponsor Responsibilities ................................................................................................................................................... 39 
5.8.1 
Site Qualification ................................................................................................................................................................................ 39 
5.8.2 
Site Initiation and Training ................................................................................................................................................................. 39 
5.8.3 
Site Authorization to Enroll ................................................................................................................................................................. 39 
5.8.4 
Interim Monitoring .............................................................................................................................................................................. 40 
5.8.5 
Site Close-out ..................................................................................................................................................................................... 40 
5.9 
Protection of Confidentiality ............................................................................................................................................... 41 
5.10 
Trial Registration ............................................................................................................................................................... 41 
5.11 
Data Collection and Data Management ............................................................................................................................. 41 
5.12 
Protocol Deviations ........................................................................................................................................................... 42 
5.13 
Study Suspension or Early Termination ............................................................................................................................. 42 
5.14 
Final Report ...................................................................................................................................................................... 42 
6 
Risk Analysis ................................................................................................................................. 42 
7 
Abbreviations ................................................................................................................................ 44 
8 
Revision Record ............................................................................................................................ 45 
9 
Appendices .................................................................................................................................... 48 
Appendix 1 – Informed Consent Form Template ........................................................................................................................... 49 
Appendix 2 – FI Episode Sample Diaries ...................................................................................................................................... 50 
Appendix 3 – FIQOL Questionnaire .............................................................................................................................................. 51 
Appendix 4 – PGI-I Questionnaire ................................................................................................................................................ 52 
Appendix 5 – Patient Goal Questionnaire ..................................................................................................................................... 53 
Appendix 6 - Device Satisfaction Questionnaire ........................................................................................................................... 54 
Appendix 7 – FI Information Brochure .......................................................................................................................................... 55 
Appendix 8 – Eclipse System Instructions for Use ........................................................................................................................ 56 
Appendix 9 – Eclipse System Use and Care Instructions for LIBERATE Study Subjects .............................................................. 57 
Appendix 10 – Cost Utilization Survey .......................................................................................................................................... 58 
 
List of Figure 
 
Figure 1. Insert (inflated state) ...................................................................................................................... 9 
Figure 2. Pump .............................................................................................................................................. 9 
Figure 3. Insert; deflated (left), and inflated (right) ...................................................................................... 10 
Figure 4. Deflated balloon ........................................................................................................................... 10 
Figure 5. Folded Insert ................................................................................................................................ 10 
Figure 6. Study Visit Schedule Schematic .................................................................................................. 16 
 
List of Tables 
Table 1. Regulators and Associated Pressures ............................................................................................ 9 
Table 2. List of Inclusion and Exclusion Criteria ......................................................................................... 12 
Table 3. Schedule of Events ....................................................................................................................... 15 
Table 4. Adverse Event Categories ............................................................................................................ 31 
Table 5. Adverse Event Severities .............................................................................................................. 32 
Table 6. Adverse Event Relationship to Device .......................................................................................... 32 
Table 7. Abbreviated Requirements for NSR Device Investigations .......................................................... 34 
 
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1 Background 
1.1 Epidemiology of FI 
Fecal incontinence (FI), also referred to as loss of bowel control or accidental bowel leakage (ABL), 
is a debilitating condition and a significant unmet need in women’s health.  Recent studies of 
community-dwelling women in the U.S. report prevalence rates of 12-25%.1,2,3,4,5 The average age of 
onset is between 47 and 55 years2,6.  This condition can be emotionally devastating, resulting in 
social isolation, and many women are unaware that help is available.  
1.2 Causes of FI 
The cause of FI is multifactorial, including congenital, neurologic, and traumatic alterations of the 
continence mechanism. Many women with FI have a history of damage to the pelvic region caused 
by pregnancy and childbirth.  Damage can involve the internal and external anal sphincters, pelvic 
floor muscles, and associated nerves (e.g., pudendal nerve).  Puerperal damage to these structures 
may not manifest until later in life, possibly due to age-related changes in rectal sensation, 
compliance, and volume, in addition to further weakening of the sphincters and pelvic floor muscles.  
Many women with FI have multiple defects in their continence system, making effective treatment 
particularly difficult.   
1.3 Available Treatments 
Existing treatments for FI have had limited sustained success. Conservative medical management, 
such as dietary modification, antimotility agents7, and biofeedback8, have demonstrated varying 
degrees of effectiveness, ranging from 50-90% for biofeedback in conjunction with other 
therapies, 9,10  Overlapping sphincter repair is one of the most common surgical approaches.  
However, long-term success rates have been less than 40% and the procedure is usually only 
applicable for certain, repairable sphincter defects.11  The implantable artificial bowel sphincter is a 
surgical device that gives the patient dynamic control of the opening and closing of the anorectal 
canal.12  This mechanism of dynamic control has shown a 42.6% effectiveness rate, compared to 
49.3% for dynamic graciloplasty; however, the high morbidity related to its invasive nature has greatly 
limited its applicability.13  Such surgical interventions also require inpatient hospitalization and 
prolonged recovery.  Recently, sacral nerve stimulation (SNS) has been used to treat FI with up to 
1. Varma MG, Brown JS, Creasman JM, et al. Fecal incontinence in females older than aged 40 years: who is at risk? Dis Colon 
Rectum 2006; 49: 841–851. 
2. Bharucha AE, Zinsmeister AR, Locke GR, et al. Prevalence and burden of fecal incontinence: a population-based study in women. 
Gastroenterology 2005; 129: 42–49. 
3. Boreham MK, Richter HE, Kenton KS, et al.. Anal incontinence in women presenting for gynecologic care: prevalence, risk factors, 
and impact upon quality of life. Am J Obstet Gynecol 2005; 192: 1637–1642. 
4. Brown HW et al. Factors Associated With Care Seeking Among Women With Accidental Bowel Leakage. Female Pelvic Med 
Reconstr Surg 2013;19: 66Y71 
5. Lawrence JM, Lukacz ES, Nager CW, et al. Prevalence and co-occurrence of pelvic floor disorders in community-dwelling women. 
Obstet Gynecol 2008; 111: 678–685. 
6. Romano, Carlo Ratto, Giovanni B. Doglietto (ed). Fecal incontinence: diagnosis and treatment (1. Ed. ed.). Milan: Springer, 2007. 
7 Sun W, Donnelly TC. Effects of loperamide oxide on gastrointestinal transit time and anorectal function in patients with chronic 
diarrhea and faecal incontinence. Scand J Gastroenterol 1997;32:34–8. 
8 Norton C, Chelvanayagam S, Wilson-Barnett J, et al. Randomized controlled trial of biofeedback for fecal incontinence. 
Gastroenterology 2003;125:1320–29. 
9 Norton C et al. Conservative Management of Fecal Incontinence in Adults. Committee of the International Consultation on 
Incontinence. Management of fecal incontinence in adults. Neuro-urol Urodyn 2010; 29(1):199-206. 
10 Hayden, D.M. et al. Fecal Incontinence: Etiology, Evaluation, and Treatment. Clin Colon Rectal Surg 2011; 24:64-70. 
11 Gutierrez et al. Long-term results of anterior sphincteroplasty. Dis Colon and Rectum 2004; 47:727-732. 
12 Wong et al. Dis Colon and Rectum 2002;45:1139 -1153. 
13 Belyaev, O, Muller, C. and Uhl, W. Neosphincter Surgery for Fecal Incontinence: A critical and Unbiased Review of the Relevant 
Literature. Surg Today 2006;36:295-303. 
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PROPERTY OF PELVALON, INC. NEITHER THIS DOCUMENT NOR THE INFORMATION HEREIN MAY BE REPRODUCED, 
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Page 7 of 58 
 
                                                     
 

 
 
 
 
83% at 12 months.  Its mechanism is not fully understood and is applicable to patients willing to 
undergo a permanent, surgical implant14,15 Injectable bulking agents, such as dextranomer in 
stabilized hyaluronic acid (Solesta™), have been used to treat FI, with a reported efficacy rate of 
52%.16  Given the risks and limitations associated with current alternatives, most FI patients are 
resigned to coping with the condition by modifying their lifestyle and using products such as pads and 
adult diapers. 
1.4 Description of the Eclipse System 
1.4.1 
Overview 
The Eclipse System is a vaginal bowel control (VBC) therapy intended to provide bowel control for 
women with fecal incontinence.  Manufactured by Pelvalon, Inc. (Sunnyvale, CA), it is comprised of 
a non-surgical device placed in the vagina (referred to as the “Eclipse Insert”) and a pressure-
regulated pump which is used to inflate and deflate the Insert.  A Sizing Kit, for use during the fitting 
process, and an evaluation Insert (referred to as the Trial Insert) are also provided.  
1.4.2 
The Sizing Kit 
The Sizing Kit is a set of reusable fitting inserts (Sizers) which consist of the same stainless steel 
base and medical grade silicone coating as the Eclipse Insert, but without the balloon that is part of 
the Eclipse system.  These reusable Sizers are available in the same base sizes as the Eclipse Insert, 
and can be reused after reprocessing in accordance with the Instructions for Use (IFU)..  
1.4.3 
The Trial Insert 
Prior to providing the Eclipse Insert to a subject, the clinician will use the Sizers and the Trial Insert 
to assess appropriate fit of the Eclipse Insert for each subject.  The Trial Insert is composed of a base 
made of medical grade silicone, polycarbonate, and stainless steel, and a balloon made from medical 
grade silicone and polyurethane. 
The Trial Insert consists of base-balloon configurations sized exactly as the Eclipse Inserts are sized 
and is intended for short-term use (1-2 weeks). This disposable Trial Insert allows the subject to try 
one or more Insert sizes (while keeping a fecal incontinence episode diary) during the Fitting Period 
before qualifying for and committing to the year-long trial of the Eclipse Insert.   
A silicone inflation tube connects to the balloon on one end, and to a self-closing luer valve (Valve) 
and cap on the other end which extends outside of the subject’s vagina.  An optional extension tube 
can be added between the existing tube and the Valve to increase the length. The Valve allows the 
user to inflate or deflate the balloon with the Pump. 
1.4.4 
The Eclipse Insert 
The Eclipse Insert and the Trial Insert look the same; this Insert is graphically depicted in Figure 1. 
The Eclipse Insert is provided as a non-sterile unit for use by a single patient and is currently available 
in a range of base sizes with two (2) different balloon sizes. It is composed of a base made of medical 
grade silicone and stainless steel, and a balloon made of medical grade silicone and polyurethane. 
14 Leroi et al.  Efficacy of sacral nerve stimulation for fecal incontinence: results of a multi-center, double-blind crossover study.  
Annals of surgery, volume 242, number 5, November 2005. 
15 Wexner et al.  Sacral nerve stimulation for fecal incontinence: results of a 120-patient, prospective, multi-center study. Annals of 
surgery, volume 251, number 3, March 2010. 
16 Graf et al.  Efficacy of dextranomer in stabilised hyaluronic acid for treatment of faecal incontinence: a randomized, sham-
controlled trial.  Lancet 2011; 377: 997-1003.  
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PROPERTY OF PELVALON, INC. NEITHER THIS DOCUMENT NOR THE INFORMATION HEREIN MAY BE REPRODUCED, 
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A silicone inflation tube connects to the balloon on one end, and to a self-closing luer valve (Valve) 
and cap on the other end which extends outside of the subject’s vagina.  The Valve allows the user 
to inflate or deflate the balloon with the Pump. An optional extension tube can be added between the 
existing tube and the Valve to increase the length. 
 
Figure 1. Insert (inflated state) 
1.4.5 
The Pump 
A pressure-regulated Pump (Figure 2) is provided to inflate and deflate the Insert. The Pump 
connects to the Insert via the Valve.  The Pump has two ends that connect to the Valve: one end for 
adding air (labeled with a “+”) and the other end for removing air (labeled with a “-“).  Air is moved 
through the Pump by squeezing the pump body. During inflation, the Pump is squeezed seven to ten 
times.  Seven pumping motions are required to adequately fill the balloon. The balloon will not over-
inflate because any excess air is vented out by the regulator. When the balloon is fully inflated, the 
internal pressure is set to the venting pressure of the regulator.  Regulators are removable so that 
different balloon pressures can be achieved.  Regulators and pumps are also designed for single-
patient use only.  Three different Regulators are available that regulate the balloon pressures to within 
the values listed in Table 1. The Pump is packaged without a regulator attached.  The “Low”, 
“Medium” and “High” Regulators are shipped separately. 
 
 
Figure 2. Pump 
 
Table 1. Regulators and Associated Pressures 
 
Regulator 
Pressure at Full 
Inflation (mmHg) 
Low 
45-57 
Medium 
70-92 
High 
114-129 
1.5 Mechanism of Action of the Eclipse System 
The Insert (refers to both the Eclipse Insert and the Trial Insert) is placed in a position similar to other 
vaginal devices, such as diaphragms, pessaries, and tampons, whose safety profiles are well-
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Page 9 of 58 
 

 
 
 
 
established.17,18,19 Insertion and removal, and inflation and deflation of the Insert, are under the 
control of the subject.   
The Insert is designed to restore bowel continence in women with FI by replacing the normal 
continence function provided by the rectum and anal canal, which is complex and multi-factorial. The 
Insert utilizes the naturally overlapping potential spaces of the vagina and rectum to inhibit (or allow) 
stool passage in a user-controlled manner. Though separated by the conformable rectovaginal 
septum, much of the vagina and rectum effectively share the same space.  When the rectum fills with 
stool, it expands, taking up more of this shared space.  This is often palpable on a vaginal exam as 
the vagina conforms to the shape of the expanded rectum.  Similarly, when an object is placed in the 
vagina, it is often palpable in the rectum.  The redundant nature of the vaginal tissue makes it naturally 
conformable without discomfort or strain.  The Insert is designed such that when it is placed in the 
vagina and is in the deflated state, the rectal space is not occupied, allowing stool to pass through 
normally (see Figure 3, left). When the Insert is inflated, the vagina conforms around it, causing a 
reduction in rectal space, which helps the patient prevent unwanted stool passage (see Figure 3, 
right).   
In Figure 4 the Insert is shown in its deflated state. The base of the Insert is flexible to allow for 
ease of insertion and removal, as shown in Figure 5.  
           
   
 
Figure 3. Insert; deflated (left), and inflated (right) 
 
 
 
Figure 4. Deflated balloon 
Figure 5. Folded Insert 
17 Lone et al. A 5 year prospective study of vaginal pessary use for pelvic organ prolapse.  Int J Gynecol Obstet. 114 (2011) 56-59. 
18 Clemons et al.  Patient satisfaction and changes in prolapse and urinary symptoms in women who were fitted successfully with a pessary for 
pelvic organ prolapse. Am J Obstet Gynecol (2004) 190, 1025-9. 
19 Bash, et al.  Review of vaginal pessaries.  Obstetrical and Gynecological Survey (2000) 55, 7, p455-460. 
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Page 10 of 58 
 
                                                     
 

 
 
 
 
1.6 Prior Investigations 
1.6.1 
Feasibility Studies 
Two feasibility studies were initially conducted to assess the fit and function of the Eclipse System in 
female subjects. These studies were approved by each site’s Institutional Review Board (IRB) as 
non-significant risk (NSR) device investigations. In total, 86 subjects were fit with the Insert who wore 
it for up to 3 months.  There were 9 device-related adverse events reported, none of which were 
classified as serious or unanticipated and all were mild (minor bleeding/lacerations from 
insertion/removal (3) or minor ecchymosis (6)) and all resolved quickly without medical intervention 
other than vaginal estrogen cream.  Subjects in these studies demonstrated a positive response to 
the impact of the Eclipse System on their FI symptoms.   
1.6.2 
LIFE Pivotal Study 
The LIFE Study (Protocol CA003) was a multi-center, prospective, open label clinical trial conducted 
at six (6) centers in the United States. As with the prior studies, all IRBs approved the trial as an NSR 
investigation. Furthermore, FDA is aware that this and the prior feasiblity studies were conducted as 
NSR investigations and did not object to this categorizatoin. The objective of this pivotal trial was to 
evaluate the safety and effectiveness of the Eclipse System for the treatment of Fecal Incontinence 
(FI) in adult women.     
A total of 200 female subjects aged 19 to 75 were enrolled in the study between August 2012 and 
October 2013. Subjects were required to experience ≥4 fecal incontinence episodes during a 2 week 
baseline diary assessment to qualify for participation.  Sixty-one (61) subjects met all study eligibility 
criteria and entered the 1 month Treatment Period to make up the Intent to Treat Cohort.  Fifty-six 
(56) subjects completed the 1 month Treatment Period without major protocol deviations to make up 
the Per Protocol Cohort. 
The primary endpoint was the percent change in the number of episodes of FI experienced while 
wearing the Insert during the 2-week assessment period (Treatment Period) as compared to the 
baseline 2-week assessment period.  Clinical effectiveness of the Eclipse System (study success) 
was defined as occurring when at least 40% of the Intent to Treat Cohort demonstrated at least a 
50% decrease in the number of FI episodes (recorded in a 2-week patient diary) after 1 month of 
treatment with the device as compared to the number of FI episodes reported during the Screening 
Period. 
Secondary endpoints were reduction in the number of incontinent days while wearing the device and 
adverse events.  Other endpoints included symptom improvement measured by the Fecal 
Incontinence Quality of Life (FIQOL), Modified Manchester Health Questionnaire (MMHQ), and 
Patient Global Impression of Improvement (PGI-I).  
At 1 month, 78.7% of the ITT Cohort (95% CI, 66-88%, p<0.0001) met the success criterion; 85.7% 
(95% CI, 74-94%, p<0.0001) met the success criterion in the Per Protocol analysis and 85.7% of 
participants considered their bowel symptoms "very much" or "much better". There was significant 
improvement in all FIQOL (all p<0.001) and MMHQ (all p≤0.007) subscales.  
There were no serious device-related adverse events reported in the trial.  Two (2) SAEs were 
reported, neither of which was related to the study device, a fractured fibula and flu symptoms 
requiring hospitalization.  Among the 117 subjects in the Safety Cohort, 93 AEs in 61 subjects were 
reported as device-related / possibly device-related, and another 26 AEs were reported in 21 subjects 
as not / unlikely device-related.   All device-related AEs were mild (78%) or moderate (22%) and none 
required any significant intervention (defined as "intervention to prevent permanent impairment / 
damage" per the AE CRF).  No device-related AEs required surgical treatment to resolve, and only 2 
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Page 11 of 58 
 

 
 
 
 
required medical intervention: topical vaginal estrogen for vaginal erythema and a topical antifungal 
for yeast infection. Modification to pre-existing Estrace usage was also required in some subjects.  
1.7 Rationale for this Trial 
The previous LIFE Study assessed safety and effectiveness of the Eclipse System (including the 
Eclipse Insert and Pump) after 1 month of use with some subjects opting to extend treatment out to 
3 months of use. The rationale for conducting this study is to characterize safety and effectiveness 
among treatment responders with longer-term follow up than the LIFE Study. Since the previous trial 
demonstrated a stable treatment effect and an acceptable safety profile between 1 and 3 months it 
is expected that use of the device between 3 and 12 months will demonstrate a similar safety and 
effectiveness profile throughout the duration of use.  
1.8 Regulatory Status of the Eclipse System 
The Eclipse System received marketing clearance from the U.S. Food and Drug Administration (FDA) 
on November 12, 2015.. 
1.9 Indications for Use 
The Eclipse System is indicated for the treatment of fecal incontinence in adult women.  
2 Study Description 
2.1 Design 
Multi-center, prospective, within-subject control, open label clinical trial. 
2.2 Target Population 
Subjects may participate in this study if they meet eligibility criteria shown in Table 2.  Appropriate 
subjects are adult females suffering from Fecal Incontinence. Fecal incontinence is defined as the 
involuntary loss of liquid or solid stool that is a social or hygienic problem. Due to the non-surgical, 
low risk, reversible nature of this treatment, subjects are not required to have previously 
attempted/failed other treatment methods. Note that final eligibility for enrollment into the Treatment 
Period involves several screening assessments.  It is anticipated that up to 625 subjects may need 
to be screened and consented to yield up to 150 subjects entering the Treatment Period for the 
effectiveness analysis. 
Safety will be evaluated based on all subjects who undergo fitting with the Eclipse System.   
Table 2. List of Inclusion and Exclusion Criteria 
Inclusions: 
General 
Eligibility 
Criteria 
1. Female sex 
2. Age 19 years or older  
3. History of FI for at least 6 months 
4. Subject willing and able to give written informed consent to participate in the study  
5. Subject can read, write and communicate fluently in English (the study diaries, 
questionnaires and instructions are only provided in English) 
6. Subject willing and able to comply with visit schedule 
7. Subject is able to physically manage the insertion and removal of the Insert1 
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Exclusions: 
Pregnancy 
Exclusion 
Criteria 
8. Vaginal childbirth within the last 18 months  
9. Currently pregnant or planning pregnancy during the study period 
10. A positive pregnancy test or, if at risk of pregnancy (i.e. of childbearing potential), 
does not have a documented method of birth control. 
Exclusions: 
Physical / 
Pelvic 
Exam 
Criteria 
 
11. Presence of fecal impaction on pelvic exam 2 
12. Presence of an open wound or tear in the vagina or anus on pelvic exam 2 
13. Atrophic vaginal tissue that would inhibit the comfortable wearing of a vaginal 
insert, as determined by symptoms or visualization on pelvic exam 2 
14. Current vaginal infection requiring treatment on pelvic exam 2 
15. Current urinary tract infection requiring treatment 3 
Exclusions: 
Current / 
Prior FI 
Treatments 
 
16. Supervised anal sphincter exercises/pelvic floor muscle training with or without 
biofeedback within the last 3 months and unwillingness to abstain from such for 
duration of study participation 
17. Use of home e-stim devices to stimulate pelvic floor muscles and unwillingness to 
abstain from such use for duration of study participation 
18. Percutaneous Tibial Nerve Stimulation (PTNS) treatment within the last 3 months 
and unwillingness to abstain from such for duration of study participation 
19. Injectable bulking agents (e.g. Solesta®) for treatment of FI within the last 3 
months and unwillingness to abstain from such for duration of study participation 
20. Current sacral nerve stimulator (SNS) implant (Interstim®) used within the last 3 
months.  If SNS unit is implanted, there must be documented evidence that the 
device has been turned "off" for the past 3 months and the patient must agree to 
abstain from use for duration of study. 
21. Presence of an artificial bowel sphincter implant 
22. Active participation in another bowel or pelvic floor disorder investigational study, if 
the treatment could affect use of the Eclipse System, its safety or effectiveness, or 
otherwise confound the results of this study 
Exclusions: 
Prior 
Surgeries 
 
23. History of surgical diversion or removal of any portion of the bowel, except 
appendectomy or cholecystectomy 
24. History of bariatric surgery  
25. Hysterectomy within the last 6 months 
26. Native tissue repair for pelvic organ prolapse within past 6 months 
27. Any history of reconstructive mesh surgery for pelvic organ prolapse or FI (mesh 
mid urethral slings are allowed) 
28. Urinary incontinence surgical procedure within past 6 months 
29. Colorectal/anal surgery such as rectopexy, sphincteroplasty, graciloplasty within 
the last 12 months 
 
 
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Exclusions: 
Concurrent 
Medical 
Conditions 
 
30. Chronic (greater than 6 months) abdominal pain in the absence of diarrhea 
31. Inflammatory bowel disease (IBD) such as Crohn’s Disease or Ulcerative Colitis 
32. Grade III or IV hemorrhoids 
33. Congenital anorectal malformation 
34. Chronic watery diarrhea (3 or more loose stools per day for 4 weeks or more) 
unmanageable by drugs or diet as primary cause of FI per review of subject 
history and baseline diary  
35. Laxative use as primary cause of FI 
36. Chronic (greater than 3 months) fecal impaction requiring ongoing treatment  
37. Rectal prolapse (mucosal or full thickness) 
38. Chronic (greater than 6 months) rectal, anal or pelvic pain 
39. History of chronic or recurrent UTIs (2 or more positive cultures within the last 6 
months or 3 or more positive cultures within the last year)  
40. History of chronic or recurrent vaginal infections (4 or more per year) within the 
last year  
41. Any pelvic organ prolapse that extends beyond the plane of the hymen  
42. Concurrent use of an intra-vaginal pessary or other device that would interfere 
with the Eclipse™ Insert placement or wearing 
43. Presence of any urogenital or colorectal fistula involving the vagina, history of a 
recurrent fistula, or history of a prior failed or complicated fistula repair. A remote 
history (≥12 months) of a single, well-healed fistula repair is allowed.  
44. Anal or pelvic (colorectal or genitourinary) malignancy within past five years 
45. History of pelvic irradiation for cancer 
46. Life expectancy of less than three years 
47. Uncontrolled and complicated autoimmune or inflammatory disorder such as 
Systemic Lupus Erythematosus, Sjogren’s Syndrome, Rheumatoid Arthritis, or 
AIDS, that could have a confounding effect on FI severity or frequency during a 
yearlong study participation 
48. Neurological disorders known to affect bowel continence, such as advanced 
Multiple Sclerosis or Parkinson’s disease 
49. Subject has an unstable condition (e.g. psychiatric disorder, recent history of 
substance abuse) or otherwise thought to be unreliable or incapable of complying 
with the requirements of the study protocol   
50. Any other significant medical condition or lifestyle factor or confounder that the 
investigator believes would interfere with study participation and/or increase 
subject risk or interpretation of the primary or secondary endpoints 
Inclusions: 
Baseline 
Diary 
51. At least 4 episodes of FI recorded during the 2-week Baseline Diary 1 
52. At least 12 out of 14 consecutive days of diary data recorded on the Baseline 
Diary1 
Inclusions: 
Device 
Fitting 
 
53. Successful fitting of the Trial Insert, i.e. device is both stable and comfortable 
while wearing 1 
54. Subject is able to physically manage the insertion and removal of the Insert 1 
Inclusions: 
Test Diary 
 
55. Subject attains a 50% reduction or more in the number of FI episodes while 
wearing the Trial Insert in the 2-week Fitting Period compared to their 2-week 
Baseline Period. 1  
56. At least 12 out of 14 consecutive days of diary data recorded on the Test Diary 1 
1   These criteria will be assessed at the appropriate follow-up visit. 
2     Subjects may be treated and re-assessed to qualify for study participation. 
3     Subjects should be treated as clinically indicated and may complete their baseline diary, but they must 
have a documented negative urine dipstick or urine culture test prior to the Initial Fitting at visit 2. 
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Page 14 of 58 
 

 
 
 
 
2.3 Recruitment  
Potential study subjects will be recruited primarily from practices of participating investigators.  All 
subject recruitment materials will be reviewed and approved by the Sponsor and the governing IRB 
prior to use.   
An estimated 625 subjects will be recruited into this study across all sites.  Subjects who qualify via 
the Baseline diary will proceed with the first fitting visit. Subjects who are successfully fit with the 
Eclipse System and qualify via the Test Diary will be eligible for treatment. Each site is expected to 
contribute approximately 7-25% of the total treatment-eligible subjects unless authorized in writing to 
over-enroll by the Sponsor. Enrollment is competitive until overall enrollment target is reached or 
study termination by the Sponsor. 
2.4 Schedule of Events 
The scheduled assessments performed at each visit are shown in Table 3.  
Table 3. Schedule of Events 
Assessment 
Screening Period 
Treatment Period  
(± 2 weeks)┬ 
 
V1 
V2 
V3 
V4 
V5 
V
6 
V7 
V8 
Unscheduled Visit 
Baseline 
Fitting Visits* 
Fit 
Confirmation 
Treatment 
Eligibility 
3 Months 
6 Months 
9 Months 
12 Months / 
Study Exit 
Informed Consent 
X 
 
 
 
 
 
 
 
 
Inclusion/Exclusion Criteria (pregnancy test done at 
baseline only, if applicable) 
X 
X 
X 
X 
 
 
 
 
 
Clean catch urine test to r/o UTI┼ 
X 
X┼ 
 
 
 
 
 
 
 
Demographics & Medical history / FI brochure 
X 
 
 
 
 
 
 
 
 
FI episode diary dispensed 
X 
 
X 
X 
X 
 
X 
 
 
FI episode diary collected & reviewed 
 
X 
 
X 
X 
X 
 
X 
 
Device fit check 
 
 
X 
 
X 
X 
X 
X 
X† 
Pelvic exam (speculum & digital rectal exam) 
X 
X 
X 
X 
X 
X 
X 
X†† 
X† 
AE and Con Med review ‡ 
 
X 
X 
X 
X 
X 
X 
X 
X 
St. Mark’s (Vaizey) Incontinence Severity Score and 
FIQOL questionnaire 
X 
 
 
 
X 
X 
X 
X 
 
PGI-I questionnaire 
 
 
 
 
X 
X 
X 
X 
 
Patient Goal questionnaire 
 
X 
 
 
X 
X 
X 
X 
 
Device Satisfaction questionnaire 
 
 
 
 
X 
X 
X 
X†† 
 
Cost Utilization survey 
X 
 
 
 
X 
 
 
X 
 
*Fitting visits are repeatable up to 2 more times for a maximum of 3 fitting visits total. 
┬Telephone follow-up calls are required in between each Treatment Visit.  
┼ If clean catch urine test is positive, the test must be repeated until either it, or a urine culture test, 
is negative before performing a Fitting Visit (Visit 2) 
 
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† If clinically indicated. 
‡ AEs recorded starting at the first Fitting Visit (Visit 2); Con Meds recorded at baseline and 
reviewed / updated at every visit. 
†† A pelvic exam and Device Satisfaction questionnaire are required at all early study exit visits after 
the first Fitting Visit (Visit 2). 
2.5 Visit Schedule 
The visit schedule is graphically represented in Figure 6. 
  
Figure 6. Study Visit Schedule Schematic 
2.6 Screening Period 
All subjects considered for the trial will be tracked on a screening log. All subjects who are screened 
and consented will be assigned a unique identification number. Study-specific procedures will be 
performed only after a subject has signed the informed consent form. It is anticipated that up to 25% 
of subjects screened will be disqualified due to not meeting the general or pelvic exam 
inclusion/exclusion criteria, and up to another 25% may fail to meet the baseline FI frequency criteria. 
2.6.1 
Pre-Screening 
Subjects may be recruited and pre-screened by telephone using the appropriate IRB-approved 
recruitment materials such as a pre-screening telephone script. Once a subject passes the pre-
screening criteria they are scheduled for a Baseline Visit. 
2.6.2 
Visit 1 - Baseline Visit 
The trial is fully explained to the subject, and their questions are answered. A copy of the signed 
informed consent form should be given to the subject and the consent process should be 
documented within their case history.  
After the subject is consented they are evaluated against the study eligibility criteria listed in Table 
2. If there is any question as to the eligibility of a subject due to unique individual circumstances, 
the Investigator or research staff should contact the Sponsor’s trial management team to discuss 
the possibility of a waiver. A written confirmation of a waiver must be maintained in the subject 
record and should be reported to the IRB, if required by the site’s IRB reporting requirements. Study 
waivers are intended to be used judiciously by sites and Sponsor.  
The following tasks are completed at this visit: 
• 
Informed Consent obtained 
• 
Inclusion/Exclusion criteria reviewed 
• 
Presentation of FI informational brochure 
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• 
Pregnancy test and confirmation of birth control method (if subject is at risk for pregnancy, 
e.g. of childbearing potential) 
• 
Clean catch urine dipstick for leukocyte esterase or nitrites┼ 
• 
Demographics and Medical History (including baseline concomitant medications) 
• 
Pelvic exam (speculum and digital rectal exam) 
• 
St. Mark’s (Vaizey) Incontinence Severity Score 
• 
FIQOL questionnaire  
• 
Cost Utilization survey  
• 
Two week FI Episode Diary (Baseline Diary) dispensed 
 
┼ If subject is positive for leukocyte esterase or nitrites by a clean catch urine dipstick test at 
baseline, they should be treated as clinically indicated (Note - this is standard of care treatment, 
not paid for by the study), and continue with screening. However, they must be negative by the 
same test, or by a urine culture test, at Visit 2 prior to being fit with the device. This test may be 
repeated at the treating investigator’s discretion. 
All subjects should be presented with an FI brochure, containing standardized general information 
about the diagnosis and treatment of Fecal Incontinence during the Baseline Visit20 (Appendix 7). 
Dissemination of this information is meant to standardize the instructions given to each potential 
subject regarding the maintenance of healthy bowel habits.  
In addition, all potential subjects should be counseled to maintain their usual diet and bowel health 
regimen as much as possible for the duration of their participation in the trial.  They should also 
continue any medications already in use for management of bowel and vaginal health for the 
duration of their participation. These medications specifically include any intra-vaginal estrogen 
creams such as Estrace® or Premarin®, and any supplements or medications for fecal 
incontinence or bowel health, such as fiber, they are using at the time of the Baseline Visit. 
Please query subjects regarding any planned dental or medical procedures or travel in the next 
several months and assess the impact on subject’s ability to keep a representative bowel diary and 
to keep appointments during the screening period (between Visit 1 and Visit 4).  
Subjects who are deemed eligible are counseled on proper FI Episode Diary completion, and 
should demonstrate a satisfactory understanding of how to complete each of the questions in the 
diary. The subject is instructed to start the Baseline Diary within the next 14 days following the 
Baseline Visit, and to complete it daily over the next 14 consecutive days. This is to ensure that the 
training received by the subject on diary completion during the Baseline Visit is fresh in their minds.  
If the subject passes the general inclusion/exclusion criteria including the pelvic exam criteria, then 
they will be scheduled to return for the Initial Fitting Visit as soon as possible within 14 days (-2/+7 
days) after their Baseline Visit.  
 
Until a site has been proctored, at the discretion of the Sponsor, there will be an exception made 
to the 21-day maximum window between Visits 1 and 2 in order to allow for bolus scheduling of 
two or more subjects at the first fitting visit (Visit 2) without it being considered a protocol deviation.  
A subject who presents with vaginal atrophy on initial exam may be prescribed a vaginal estrogen 
cream such as Estrace® or Premarin® if not contraindicated, and after all risks and benefits have 
been discussed with the subject (refer to the prescribing information of the relevant vaginal 
20 NIH Publication No. 13-4866. Dec. 2012. Available online at http://www.niddk.nih.gov/health-information/health-topics/digestive-
diseases/fecal-incontinence/Documents/Fecal_Incontinence_508.pdf 
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estrogen cream). Subject should return within the next 2 – 6 weeks to be re-assessed by the study 
clinician at the Initial Fitting Visit.  
If the subject fails any other pelvic exam criteria that allow for re-assessment, but they are otherwise 
eligible, they may be scheduled for the Initial Fitting Visit up to a maximum of 6 weeks from their 
Baseline Visit, based upon clinician evaluation of the length of time needed for the clinical findings 
to resolve or stabilize adequately in order for the subject to proceed safely and comfortably with 
fitting of a vaginal device.  
 
Note: The Baseline Diary should still be started within the next 14 days after the initial Baseline 
Visit, regardless of the length of time between the Baseline Visit (Visit 1) and the scheduled Initial 
Fitting Visit (Visit 2). However, subjects will be allowed to repeat (stop and restart) their Baseline 
diary if during the two weeks recorded there were unusual or exceptional circumstances outside of 
the subject’s control e.g. illness, injury, natural catastrophe, or family emergency. Only the repeat 
diary data will be used to qualify the subject at Visit 2. Both original and repeat diaries must be 
retained. Pelvalon should be notified immediately and the rationale for allowing a subject to repeat 
their diary provided. The case will be evaluated by the Executive Committee, and a documented 
written approval must be obtained prior to using the repeat diary to calculate the subject's eligibility 
at Visit 2.  
 
As per the study inclusion criteria, the diary should span 14 consecutive days, with no more than 2 
missing days of data between Visit 1 and Visit 2.   
2.6.3 
Visit 2 - Initial Fitting Visit - 14 days (-2/+7 days) from Baseline Visit 
Subjects are first evaluated for the frequency of their FI episodes according to their two-week 
Baseline Diary. The subject must have completed at least 12 of the 14 consecutive days of the 
Baseline Diary and have documented at least 4 episodes of major or minor soiling (not staining) on 
their Baseline Diary in order to continue in the trial. If either of these criteria are not met, then the 
subject is exited from the trial as a screen failure.  
 
Partial days of data entry should be counted as full days for the purposes of calculating eligibility. 
If the subject continues to qualify for the study based on their FI frequency, they will be asked to 
undergo a pelvic exam and fitting with the Trial Insert.  
For subjects who previously failed any pelvic exam inclusion/exclusion criteria that allow re-
evaluation, their Initial Fitting Visit may be extended up to 6 weeks from the Baseline Visit (without 
being considered a protocol deviation). The previously failed inclusion/exclusion criteria must be 
re-evaluated during the Initial Fitting Visit pelvic exam, and must be resolved in order for the subject 
to continue in the trial. Otherwise, they are exited from the study as a screen failure.  
For subjects who were prescribed an estrogen regimen, if the clinician determines that the vaginal 
tissue has adequately responded to the vaginal estrogen cream and the subject is willing to 
continue the use of the estrogen cream throughout the remainder of their study participation, they 
may continue with the Initial Fitting Visit. Otherwise, they are exited from the study as a screen 
failure. 
The following tasks are completed at this visit: 
• 
Inclusion/exclusion criteria reviewed 
• 
Baseline Diary reviewed 
• 
Patient Goal questionnaire – goal identification 
• 
Pelvic exam (speculum and digital rectal exam) 
• 
Trial Insert fitting  
• 
AEs and Concomitant Medications reviewed 
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Successful fitting with the Trial Insert is defined as an insert that is stable, in the proper position, 
provides sufficient rectal occlusion based on a digital rectal exam, and is comfortable for the 
subject. The clinician may try as many different sizes of the Trial Insert as they and the subject 
agree are tolerable to the subject at the Initial Fitting Visit. If the subject cannot obtain a suitable fit 
during this Initial Fitting Visit and/or decides to withdraw, the subject is exited from the trial as a 
screen failure. 
Per the eligibility criteria, during the Fitting Visits the subject must demonstrate the ability to properly 
insert and remove the Trial Insert and inflate and deflate the Insert as needed using the Pump. 
If the subject meets the Baseline Diary and Initial Fitting Visit criteria, they are instructed on proper 
use and care of the Eclipse System (Appendix 9), and are scheduled for a Fit Confirmation Visit 
within 7 days (-5/+7 days) from the Initial Fitting Visit.  
 
The follow up visit should be scheduled as close to 7 days post-fitting as possible to allow the 
subject enough time to accommodate to the device. However, the subject should be seen earlier 
in the window (as soon as possible) if they are experiencing signs of an improper fit (discomfort or 
lack of effectiveness), a device-related adverse event, or any of the following: 
- 
Foul odor or excessive vaginal discharge 
- 
Any difficulty urinating or defecating 
- 
Significant bleeding not associated with menstruation 
- 
Unusual pelvic pain or discomfort 
 
If the subject is a screen failure based on their Baseline Diary or pelvic exam findings, the subject 
will be exited from the study without completing the Patient Goal questionnaire or Trial Insert fitting. 
If the subject is a screen failure based on unsuccessful Trial Insert fitting, any AEs related to the 
Trial Insert fitting procedure must be reported. 
2.6.3.1 Fitting Procedure 
The fitting procedure should proceed in accordance with the Eclipse System Instructions for Use 
(IFU). (Appendix 8).  
2.6.3.2 Eclipse System Use and Care Instructions 
Upon successful fitting with the Trial Insert, a copy of the Eclipse System Use and Care Instructions 
for LIBERATE Study Subjects (Appendix 9) which apply to the Eclipse System (including the 
Eclipse Insert, Trial Insert, and the Pump) should be reviewed and given to the subject to take 
home with them. 
2.6.4 
Telephone Contact (After Initial Fitting Visit) 
Within 2-3 days of the Initial Fitting Visit the subject should be contacted by phone to ask about fit 
and comfort. The next study visit should be confirmed with the subject during this phone call.  
2.6.5 
Visit 2a / 2b – Repeat Fitting Visits (Optional) – 7 days (-5/+7 days) from the 
Initial Fitting Visit 
Evaluation of fit over multiple visits is standard clinical practice for many vaginal devices as it is 
often difficult to determine if the device will remain stable and comfortable until the subject wears it 
during their routine daily activities. A subject may undergo refitting, resulting in being sent home 
with a different size of the Trial Insert, up to two more times after the Initial Fitting Visit (for a 
maximum of 3 Fitting Visits in total) before they either exit the trial as a screen failure, or enter the 
final phase of screening and complete a 2-week Test Diary while wearing the fitted device. 
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If by the subject’s verbal report at the telephone contact following Visit 2 they indicate there may 
be a problem with the fit of the Trial Insert, the subject can be offered a repeat Fitting Visit. If there 
are no issues reported or identified during the follow-up pelvic exam, the subject may proceed 
straight to the Fit Confirmation Visit #3. If a repeat fitting is performed, the following tasks are 
completed: 
• 
Inclusion/exclusion criteria reviewed 
• 
Pelvic exam (speculum and digital rectal exam) 
• 
Insert fitting as per the Fitting Procedure in Appendix 8 
• 
AEs and Concomitant Medications reviewed 
• 
Device satisfaction questionnaire, only if subject is being exited as a screen fail 
 
If a successful fit with the Trial Insert is determined by the clinician to be unattainable, the subject 
is classified as a screen failure, and the Insert is removed. All remaining scheduled activities for 
Visit 2a / 2b will still be completed and the subject will be exited from the study.  
If a suitable fit is attained with a different sized Trial Insert, then the subject is re-instructed on 
proper use and care of the Eclipse System (Appendix 9), and is scheduled for a Fit Confirmation 
Visit within 7 days (-5/+7 days) from the Repeat Fitting Visit.  
 
The follow up visit should be scheduled as close to 7 days post-fitting as possible to allow the 
subject enough time to accommodate to the device. However, the subject should be seen earlier 
in the window (as soon as possible) if they are experiencing signs of an improper fit (discomfort or 
lack of effectiveness), a device-related adverse event, or any of the following: 
 
- 
Foul odor or excessive vaginal discharge 
- 
Any difficulty urinating or defecating 
- 
Significant bleeding not associated with menstruation 
- 
Unusual pelvic pain or discomfort 
2.6.6 
Telephone Contact (After Repeat Fitting Visits) 
Telephone contact should be initiated after any repeat fitting visits following the same guidelines 
as the Initial Fitting Visit (Section 2.6.4).  
2.6.7 
Visit 3 - Fit Confirmation Visit - 7 days (-5/+7days) from the final Fitting Visit 
The subject is evaluated for a continued good fit of the Trial Insert, as described in Appendix 8 
and the following tasks are completed: 
• 
Pelvic exam (speculum and digital rectal exam) 
• 
AEs and Concomitant Medications reviewed 
• 
Device satisfaction questionnaire, only if subject is being exited as a screen fail 
• 
Two week FI Episode Diary (Test Diary) dispensed, only if subject continues to meet all 
eligibility criteria 
• 
Order the corresponding Eclipse Insert, only if subject continues to meet all eligibility 
criteria 
 
If per clinician assessment during the pelvic exam a suitable fit with the Trial Insert is deemed to 
be unattainable, the subject is classified as a screen failure and the Insert is removed. All other 
scheduled activities for Visit 3 will still be completed (excluding dispensing a Test Diary and 
ordering the Eclipse Insert) and the subject will be exited from the study. 
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Based upon the fitting rate observed in the LIFE (CA003) Trial, it is estimated that approximately 
24% of subjects who have an Initial Fitting Visit may be disqualified due to not achieving a stable 
and comfortable fit of the Insert. This fitting rate is comparable to fitting rates observed with other 
vaginal devices.21, 22 
If a successful fit has been confirmed, the subject is re-instructed on proper use and care of the 
Eclipse System (Appendix 9) and on the proper completion of the two week Test Diary, and is 
scheduled for their final Treatment Eligibility Visit within 14 days (-2/+7days) from the Fit 
Confirmation Visit.  
The subject is instructed to start the Test Diary within the next 7 days following the Fit Confirmation 
Visit while wearing the Trial Insert. This is to ensure that the training received by the subject on 
diary completion during the Fit Confirmation Visit is fresh in the subject’s mind. If a subject is 
expecting her menstrual cycle to begin during the next 14 days and she chooses not to wear the 
Trial Insert during menstruation, she may delay the start of the Test Diary by up to two weeks 
(without being considered a protocol deviation) since collection of efficacy data would be 
inappropriate during a period of time when the device is not being worn. The Test Diary should be 
started the day after menstruation ends.  
In addition, subjects will be allowed to repeat (stop and restart) their Test diary if during the two 
weeks recorded there were unusual or exceptional circumstances outside of the subject’s control 
e.g. illness, injury, natural catastrophe, or family emergency. Only the repeat diary data will be used 
to qualify the subject at Visit 4. Both original and repeat diaries must be retained. Pelvalon should 
be notified immediately and the rationale for allowing a subject to repeat their diary provided. The 
case will be evaluated by the Executive Committee, and a documented written approval must be 
obtained prior to using the repeat diary to calculate the subject's eligibility at Visit 4.  
 
As per the study inclusion criteria, the diary should span 14 consecutive days, with no more than 2 
missing days of data between Visit 3 and Visit 4.  
There will be no opportunities to repeat the Test Diary data collection due to missing days of data, 
but the Treatment Eligibility Visit (Visit 4) may be re-scheduled if interrupted by a menstrual cycle, 
illness, injury, natural catastrophe, or family emergency to allow for 12-14 days of diary data 
collection (without it being considered a protocol deviation).  
2.6.8 
Visit 4 – Treatment Eligibility Visit - 14 days (-2/+7 days) after Visit 3 
The following tasks are completed at this visit: 
• 
Two week Test Diary review 
• 
Pelvic exam (speculum and digital rectal exam) 
• 
AEs and Concomitant Medications reviewed 
• 
Device satisfaction questionnaire, only if subject is being exited as a screen fail 
• 
Two week FI Episode Diary (Treatment Diary) dispensed (for use prior to the 3 month visit), 
only if subject continues to meet all eligibility criteria 
• 
Eclipse Insert dispensed, only if subject continues to meet all eligibility criteria 
 
The Test Diary is assessed for completeness and for the number of fecal incontinence episodes 
compared to baseline. Subjects who meet the Visit 4 Test Diary inclusion criteria by (a) recording 
21 Mutone et al. Factors which influence the short-term success of pessary management of pelvic organ prolapse.  American Journal 
of Obstetrics and Gynecology, December, 2005, 193, 89-94. 
22 Clemons et al. Risk factors associated with an unsuccessful pessary fitting trial in women with pelvic organ prolapse. American 
Journal of Obstetrics and Gynecology, 2004.  190, 345-50. 
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a minimum of 12 out of 14 consecutive days of diary data and (b) achieving a 50% or greater 
reduction in the average number of FI episodes (major or minor soiling) on their Test Diary 
compared to their Baseline Diary will be enrolled into the Treatment Period of the study. Partial 
days of data entry should be counted as full days for the purposes of calculating eligibility. 
Subjects who do not meet the Visit 4 Test Diary criteria as described above or who decide to 
withdraw will be classified as screen failures. If the subject is classified as a screen failure, all other 
scheduled activities for Visit 4 will still be completed (except for dispensing a Treatment Diary and 
the Eclipse Insert) and the subject will be exited from the study. 
If the subject continues to meet all eligibility criteria, she will be given the same sized Eclipse 
Insert as the Trial Insert used during the Test Diary, and the used Trial Insert will be disposed of 
at the site, unless directed otherwise by the Sponsor or unless there is a potential product 
malfunction associated with the used Trial Insert, in which case it will be returned to the Sponsor 
for investigation.  The subject should continue to use the same Pump.  The subject is to be re-
counseled on the requirements of the Treatment Period of the protocol, on the proper use and 
care of the Eclipse System (Appendix 9), and on proper completion of the Treatment Diary.  
The subject is instructed to complete the Treatment Diary while wearing the Eclipse Insert for a 
consecutive 14 day (2 week) period just prior to the next scheduled visit at 3 months (± 2 weeks) 
after Visit 4.  
2.7 Treatment Period 
Subjects who enter the Treatment Period will return for scheduled visits at 3, 6, 9, and 12 months 
after Visit 4. All eligible subjects will complete a 2-week Treatment Diary during the last 2 weeks 
prior to the 3, 6 and 12 month visits.  There is no Treatment Diary required at the 9 month visit. 
Subjects will be instructed to complete the diary for 14 consecutive days while wearing the Eclipse 
Insert. The timing of the start and/or completion of the Treatment Diary may be adjusted by up to 2 
weeks (without being considered a protocol deviation) if a subject’s menstrual cycle interrupts their 
wearing of the Eclipse Insert during the two-weeks when the Treatment Diary is scheduled, 
rendering assessment of effectiveness during this period of time inappropriate.  
In addition, subjects will be allowed to repeat (stop and restart) their Treatment Diary if the two 
weeks recorded were unusual or unrepresentative of their true condition due to circumstances 
outside of their control e.g. illness, injury, natural catastrophe, or family emergency. Only the repeat 
diary data will be data entered. Both original and repeat diaries must be retained. Pelvalon should 
be notified immediately and the rationale for allowing a subject to repeat their diary provided. The 
case will be evaluated by the Executive Committee, and a documented written approval must be 
obtained prior to using the repeat diary for data entry.  
If any subject arrives at a 3, 6, or 12 month visit with less than 10 days of completed diary data, 
they will be given one opportunity to reschedule the follow up visit as soon as possible within the 
next two weeks while completing a new Treatment Diary for the remainder of the required 14 
consecutive day diary period.  After the second attempt, any non-completed diary will be treated as 
missing data. 
The subject will undergo a pelvic exam at each visit in order to verify proper use of the Eclipse 
Insert and adequate hygiene, as well as to assess any adverse events. 
2.7.1 
Telephone Contacts (Between Visit 4 and Visit 5) 
The subject should be contacted by phone twice between clinic appointments at one month 
intervals to ensure she is following the instructions for use, is not experiencing any technical or 
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Page 22 of 58 
 

 
 
 
 
medical problems while wearing the Eclipse Insert, and to remind her to complete the Treatment 
Diary at the required time. 
2.7.2 
Visit 5 – 3 Months (± 2 weeks) after Visit 4 
Subjects are evaluated for the frequency of their FI episodes according to their two week Treatment 
Diary, and are evaluated for continued fit and safety of the Eclipse Insert. 
The following tasks are completed at this visit: 
• 
Two week Treatment Diary reviewed 
• 
St. Mark’s (Vaizey) Incontinence Severity Score calculated 
• 
FIQOL questionnaire administered 
• 
PGI-I questionnaire administered 
• 
Patient Goal questionnaire administered 
• 
Cost Utilization survey administered 
• 
Device Satisfaction questionnaire administered 
• 
Pelvic exam (speculum and digital rectal exam) 
• 
AEs and Concomitant Medications reviewed 
• 
Two week Treatment Diary dispensed (for use prior to the 6 month visit) 
 
The subject is re-counseled on the requirements of the Treatment Period of the protocol, on the 
proper use and care of the Eclipse System (Appendix 9) and proper completion of the Treatment 
Diary.  
The subject is instructed to complete the Treatment Diary while wearing the Eclipse Insert for a 
consecutive 14-day (2 week) period just prior to the next scheduled visit.  
2.7.3 
Telephone Contacts (Between Visit 5 and Visit 6) 
The subject should be contacted by phone twice between clinic appointments at one month 
intervals to ensure she is following the instructions for use, is not experiencing any technical or 
medical problems while wearing the Eclipse Insert, and to remind her to complete the Treatment 
Diary at the required time. 
2.7.4 
Visit 6 – 6 Months (± 2 weeks) after Visit 4 
Subjects are evaluated for the frequency of their FI episodes according to their two week Treatment 
Diary, and are evaluated for continued fit and safety of the Eclipse Insert. 
The following tasks are completed at this visit: 
• 
Two week Treatment Diary reviewed 
• 
St. Mark’s (Vaizey) Incontinence Severity Score calculated 
• 
FIQOL questionnaire administered 
• 
PGI-I questionnaire administered 
• 
Patient Goal questionnaire administered 
• 
Device Satisfaction questionnaire administered 
• 
Pelvic exam (speculum and digital rectal exam) 
• 
AEs and Concomitant Medications reviewed 
 
The subject is re-counseled on the requirements of the Treatment Period of the protocol, and on 
proper use and care of the Eclipse System (Appendix 9). A Treatment Diary is not dispensed at 
Visit 6 and is not required to be completed by the subject prior to Visit 7. 
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2.7.5 
Telephone Contacts (Between Visit 6 and Visit 7) 
The subject should be contacted by phone twice between clinic appointments at one-month 
intervals to ensure she is following the instructions for use and is not experiencing any technical or 
medical problems while wearing the Eclipse Insert. 
2.7.6 
Visit 7 – 9 Months (± 2 weeks) after Visit 4 
Subjects are evaluated for continued fit and safety of the Eclipse Insert. 
The following tasks are completed at this visit: 
• 
St. Mark’s (Vaizey) Incontinence Severity Score calculated 
• 
FIQOL questionnaire administered 
• 
PGI-I questionnaire administered 
• 
Patient Goal questionnaire administered 
• 
Device Satisfaction questionnaire administered 
• 
Pelvic exam (speculum and digital rectal exam) 
• 
AEs and Concomitant Medications reviewed 
Two week Treatment Diary dispensed (for use prior to the 12 month visit) 
 
The subject is re-counseled on the requirements of the Treatment Period of the protocol, on 
proper use and care of the Eclipse System (Appendix 9) and proper completion of the Treatment 
Diary.  
The subject is instructed to complete the Treatment Diary while wearing the Eclipse Insert for a 
consecutive 14-day (2 week) period just prior to the next scheduled visit.  
2.7.7 
Telephone Contacts (Between Visit 7 and Visit 8) 
The subject should be contacted by phone twice between clinic appointments at one month 
intervals to ensure she is following the instructions for use, is not experiencing any technical or 
medical problems while wearing the Eclipse Insert, and to remind her to complete the Treatment 
Diary at the required time.  
2.7.8 
Visit 8 – 12 Months (± 2 weeks) after Visit 4 
Subjects are evaluated for the frequency of their FI episodes according to their two week Treatment 
Diary, and for safety of the Eclipse Insert. 
The following tasks are completed at this visit: 
• 
Two week Treatment Diary reviewed 
• 
St. Mark’s (Vaizey) Incontinence Severity Score calculated 
• 
FIQOL questionnaire administered 
• 
PGI-I questionnaire administered 
• 
Patient Goal questionnaire administered 
• 
Cost Utilization survey administered 
• 
Device Satisfaction questionnaire administered 
• 
Pelvic exam (speculum and digital rectal exam) 
• 
AEs and Concomitant Medications reviewed 
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Page 24 of 58 
 

 
 
 
 
2.7.9 
Unscheduled Visits 
A subject may return to clinic at any point during the Screening Period or Treatment Period, if 
needed.  During an Unscheduled Visit, the investigator may perform a standard medical interview 
and physical examination, including a pelvic examination or Insert re-sizing, if appropriate.  All 
assessments, and any abnormal findings, including AEs and/or product malfunctions, will be 
documented in the appropriate case report forms. 
2.8 Re-sizing during Treatment Period 
If at any time during or after Visit 5 (the 3-month time point visit), an Insert no longer fits appropriately 
as assessed by a clinician during a pelvic exam, re-sizing of the Insert may be performed. The Insert 
may be re-sized at the treatment visit or at an Unscheduled Visit in between Treatment Visits per the 
following steps:  
1. If changing to a different Sized Insert, use one or more of the Sizers to determine the next 
appropriate sized Trial Insert, and send the subject home with the Trial Insert. Complete a 
Fitting CRF, and order the corresponding Eclipse Insert from Pelvalon immediately so it arrives 
in time for the follow-up Fit Confirmation Visit. Complete either the Treatment Pelvic Exam CRF 
or an Unscheduled Visit CRF, as appropriate.  
2. Schedule a follow up visit within 7 days (-5/+7 days) to confirm the Trial Insert fit is comfortable 
and stable by pelvic exam. The follow up visit should be scheduled as close to 7 days post-
fitting as possible to allow the subject enough time to accommodate to the device. However, 
the subject should be seen earlier in the window (as soon as possible) if they are experiencing 
signs of an improper fit (discomfort or lack of effectiveness), an adverse event or any of the 
following: 
 
- 
Foul odor or excessive vaginal discharge 
- 
Any difficulty urinating or defecating 
- 
Significant bleeding not associated with menstruation 
- 
Unusual pelvic pain or discomfort 
 
3. If successfully re-sized, dispose of the Trial Insert and dispense the same sized Eclipse Insert 
and instruct the subject to begin her next Treatment Diary as scheduled. The start of the 
Treatment Diary should be delayed, if necessary, so that it begins seven days or more after 
the newly sized Eclipse Insert is dispensed. 
4. Steps 1-3 may be repeated as needed.   
2.9 Study Exit 
A Study Exit CRF will be completed for each subject who is consented in the trial. Participation in the 
study is considered complete if the subject completes all end-of-study assessments and 
questionnaires at the final 12 month time point.  
A subject’s participation may be discontinued early for any of the following reasons:  
• 
Failure to meet screening eligibility criteria at any time after Visit 2 
• 
Withdrawal of consent 
• 
Adverse event preventing further study participation 
• 
Investigator decision / determination that it is in the subject’s best interest 
• 
Termination of the study for any reason 
• 
Lost to follow-up: requires documentation of at least 3 attempts to contact the subject by 
phone and/or email, and a certified letter (with request to return the investigational device)  
• 
Subjects who become pregnant will be discontinued from the trial 
 
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For all subjects who were fit with the Eclipse System at Visit 2 and exit the study prior to or at Visit 4 
(Treatment Eligibility Visit), AEs and ConMeds will be reviewed and a pelvic exam and the Device 
Satisfaction questionnaire will be administered, as per Table 3.  
For subjects who exit the study after Visit 4 (Treatment Eligibility Visit) but before Visit 8 (12 Months) 
AEs and ConMeds will be reviewed, and a pelvic exam and all required questionnaires per Table 3 
will be administered.  
To compensate for time spent during study visits, subjects may receive compensation as detailed in 
the final IRB-approved consent form and as agreed upon by the Sponsor and the Site per the Clinical 
Trial Agreement. 
2.10 Questionnaires and Surveys 
2.10.1 FI Episode Diary 
Subjects will be provided a Diary (Appendix 2) to record each bowel movement, including the type 
of episode (normal bowel movement, staining, minor soiling or major soiling), whether the bowel 
movement was “urgent” (yes or no) and the stool description according to the Bristol Stool Score 
(ranging from 1 “separate hard lumps” to 7 “liquid consistency with no solid pieces”). The Baseline 
Diary is dispensed at Visit 1 (Baseline Visit), the Test Diary is dispensed at Visit 3 (Fit Confirmation 
Visit), and the Treatment Diary is dispensed at Visit 4 (Final Eligibility Visit), and at the 3 month and 
9 month scheduled visits during the Treatment Period. The Test Diary and the Treatment Diary 
also ask if the subject is wearing the Insert at the time of each recorded episode.   
Only minor or major soiling are counted towards the number of FI episodes in any two-week diary 
period, used in the study endpoint analyses (see Section 3.2). 
2.10.2 St. Mark’s (Vaizey) Incontinence Severity Score 
The St. Mark’s (Vaizey) Incontinence Severity Score is a measure of severity of FI symptoms, which 
has been shown to correlate with improvement in frequency of FI episodes and subjects’ 
perceptions of relief. 23,24,25  This score reflects the severity of FI and ranges from 0 (complete 
continence) to 24 (complete incontinence). The survey will be administered verbally to subjects by 
site personnel at Visit 1 (Baseline Visit), and at 3, 6, 9 and 12 months during the Treatment Period. 
2.10.3 Fecal Incontinence Quality of Life Questionnaire   
The Fecal Incontinence Quality of Life (FIQOL) scale (Appendix 3) is a 41-item, validated 
questionnaire completed by the subject. 26  FIQOL has 4 subscales: lifestyle, coping/behavior, 
depression/self-perception and embarrassment.  The FIQOL questionnaire will be completed by 
subjects at Visit 1 (Baseline Visit) and at 3, 6, 9 and 12 months during the Treatment Period. 
2.10.4 PGI-I Questionnaire 
The Patient Global Impression of Improvement (PGI-I) (Appendix 4) is a validated global index 
that may be used to rate the response of a condition to a therapy on a scale from 1 (Very much 
better) to 7 (Very much worse). It is a simple, direct, easy to use scale that is intuitively 
23 Vaisey, CJ, et al Gut 1999;44:77-80 doi:10.1136/gut.44.1.77 
24 Deutekom M, Terra MP, Dobben AC, Dijkgraaf MG, Felt-Bersma RJ, Stoker J, Bossuyt PM: Selecting an outcome measure for 
evaluating treatment in fecal incontinence. Dis Colon Rectum 2005, 48:2294-2301. 
25 Maeda Y. Does the St. Mark's incontinence score reflect patients' perceptions? A review of 390 patients. Dis Colon Rectum. 2008 
Apr;51(4):436-42 
26 Rockwood et al.  Fecal Incontinence Quality of Life Scale.  Dis Colon Rectum 2000;43:9-16. 
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understandable to subjects and to clinicians. To date it has been most often used to assess the 
subjects’ response to various treatments for urinary incontinence.27 In this study we used the PGI-
I questionnaire, replacing urinary incontinence with fecal incontinence, to assess the subject’s 
response to treatment with the Eclipse System for fecal incontinence. The PGI-I questionnaire will 
be completed by subjects at 3, 6, 9 and 12 months during the Treatment Period. 
2.10.5 Patient Goal Questionnaire  
At the Visit 2 subjects will be asked to specify a single patient-centered goal describing what a 
successful improvement in FI symptoms would mean for them.  For example, they may identify 
“confidence in attending social events” or “ability to exercise without incontinence.”  At the 3, 6, 9 
and 12 month visits subjects will rank how well they were able to meet their goal while wearing the 
Eclipse Insert using a 7-point scale (Appendix 5) ranging from “I have met and exceeded my goal” 
(best case) to “I have moved further away from my goal” (worst case). The patient goal categories 
are based on results from a survey of women undergoing pelvic floor dysfunction surgery. 28  
2.10.6 Device Satisfaction Questionnaire 
Subjects who are fit at least once with the Trial or Eclipse Insert will be asked to complete a Device 
Satisfaction Questionnaire (Appendix 6). The questionnaire contains questions related to 
perceptions of device comfort, satisfaction with usage and features, and impact on daily activities.  
Subjects who Screen Fail but have been fit at least once with the Insert will be asked to complete 
this questionnaire just prior to their study exit. Subjects who successfully enter the Treatment 
Period will be asked to complete this questionnaire at 3, 6, 9 and 12 months during the Treatment 
Period (or at study exit if they end their participation in the trial early).  
2.10.7 Cost Utilization Survey 
Subjects will be asked to complete a Cost Utilization survey (Appendix 10) in order to capture the 
direct medical and non-medical (out of pocket) and indirect non-medical costs related to treating FI 
in the three months prior to Visit 1 (Baseline Visit) and again at the 3 and 12 month time points. 
The data will be used to perform a cost analysis of the Eclipse System compared to alternative 
therapies. 
3 Statistics 
3.1 Study Design 
This is a 1-year, multicenter, within-subject control, open-label, single-arm study to evaluate the 
durability of the safety and effectiveness of the Eclipse™ System after 3 and 12 months of use. All 
subjects will act as their own control. Subjects will be fitted, and refitted if necessary, with the Trial 
Insert during the Screening Period.  Subjects who successfully complete the Screening Period will 
be considered as treatment-eligible and will be fitted with the Eclipse Insert and begin the 12 month 
Treatment Period.  Subjects who do not successfully complete the Screening Period will be 
classified as screen fails and will not continue into the Treatment Period. 
27 Yalcin I, Bump R. Validation of two global impression questionnaires for incontinence. Am J Obstet Gynecol 2003;189:98-101.  
28 Kathie L. Hullfish, Viktor E. Bovbjerg, Jennifer Gibson, William D. Steers Patient-centered goals for pelvic floor dysfunction 
surgery: What is success, and is it achieved? American Journal of Obstetrics and Gynecology, Volume 187, Issue 1, July 2002, 
Pages 88-92  
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3.2 Derivations and Definitions 
The baseline period is the period prior to the Initial Fitting Visit.  Results from this period, using 
either the Baseline Diary or assessments conducted at Visit 1, will be the baseline results.  
Change from baseline is calculated as (visit result) – (baseline result). 
Percent change from baseline is calculated as 100*(change from baseline) / (baseline result). 
An FI episode is defined as major soiling or minor soiling, but does not include staining alone, as 
recorded on Baseline Diary, Test Diary or Treatment Diaries, each defined as follows: 
- 
Staining: Stain of stool on undergarment, pad, clothing, or skin (does not count as an FI 
episode).  
- 
Minor soiling:  Stool leakage that is more than staining, but did not require an immediate 
change of undergarment, pad, or clothing (e.g. a pebble sized piece of stool or teaspoon of 
liquid stool).  
- 
Major soiling:  An accident large enough to require an immediate change of 
undergarment, pad, or clothing (e.g. most of a bowel movement).  
A bowel movement is defined as urgent if the subject checks: “I had to rush to the restroom 
immediately.” Note: “Urgent” can be marked regardless of whether you made it to the toilet in time 
(for a normal bowel movement) or not (resulting in leakage).” 
The following will be calculated for each diary period using the information entered in the FI 
Episode Diaries for each subject (Baseline Diary, Test Diary, and Treatment Diaries): 
Average number of FI episodes per week: 7 * (# episodes) / (# days of diary entry) 
Average number of FI days per week: 7 * (# of days with ≥1 FI episode) / (# days of diary entry) 
Screen Failure: A subject who does not successfully complete the Screening Period.  This could be 
due to failing any of the general inclusion/exclusion criteria such as age or FI frequency by baseline 
diary assessment, unsuccessful fitting (as determined before or at Visit 4), failure to record a 
minimum of 12 days of diary data after successful fitting (i.e. Test Diary), or failure to demonstrate a 
50% or greater reduction in the average number of FI episodes in the Test Diary as compared to 
the Baseline Diary. 
Treatment-eligible Subject (Enrolled): A subject who successfully completes the Screening Period 
and enters the Treatment period is considered enrolled. This is defined as a subject having a 
confirmed successful fitting (as determined at Visit 3), having recorded a minimum of 12 out of 14 
consecutive days of diary data after a successful fitting (i.e. on their Test Diary), and having 
demonstrated at least a 50% reduction in the average number of FI episodes in the Test Diary at 
Visit 4 as compared to the Baseline Diary. 
Treatment Responder: An enrolled subject who demonstrates at least a 50% reduction in the 
average number of FI episodes per week on her Treatment Diary compared to her Baseline Diary is 
a responder for that time period. An enrolled subject must also have at least 10 out of 14 
consecutive days of recorded diary data on her Treatment Diary to be defined as a responder for 
that time period.   
Treatment Non-Responder: An enrolled subject who does not demonstrate at least a 50% reduction 
in the average number of FI episodes per week on her Treatment Diary compared to her Baseline 
Diary, is a non-responder for that time period.  An enrolled subject with less than 10 out of 14 
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consecutive days of recorded diary data on her Treatment Diary will also be classified as a non-
responder for that time period.  
3.3 Analysis Populations 
The Safety Population will include all subjects exposed to any part of the Eclipse System during or 
after Visit 2 (Initial Fitting Visit).  This will include all subjects who were unsuccessfully fitted, and 
screen failures. This will be the primary analysis population for all safety analyses. 
The Intent-to-Treat (ITT) Population will include all subjects who are successfully fit with the Eclipse 
Insert, successfully complete Visit 4, and enter the Treatment Period.   
The Per-Protocol (PP) Population will include all subjects in the ITT population who complete Visit 5 
(Month 3 Visit), complete at least 10 out of 14 consecutive days of diary data at each time point in 
the study Treatment Period, and have no major protocol deviations. 
3.4 Hypotheses 
The null hypothesis is that the proportion of treatment responders at 3 months is no more than 
40%, and the alternative hypothesis is that the proportion of treatment responders at 3 months is 
more than 40%:  
H0: π ≤ 0.40  
 
HA: π > 0.40 
3.5 Endpoints 
The primary effectiveness endpoint is the proportion of treatment responders at the 3 month time 
point in the ITT population. 
Secondary effectiveness endpoints are: 
- 
The proportion of responders at the 3, 6 and 12 month time points in the PP population. 
- 
The change from baseline in mean scores on subject-reported outcomes related to 
symptoms and quality of life as reported by St. Mark’s (Vaizey) Incontinence Severity 
Score, and FIQOL at the 3, 6, 9 and 12 month time points 
- 
PGI-I scores at the 3, 6, 9 and 12-month time points 
 
The safety endpoint is the safety of the device, as assessed by the number of device-related 
(Eclipse System) adverse events and device –related serious adverse events, as adjudicated by 
the Clinical Events Committee (CEC). 
 
Subjects who are screen failures will not be included in the effectiveness endpoint analysis. 
However, their data will be reviewed to understand reasons for screen failure.  All subjects in whom 
the device was inserted, even if just for fitting, will be included in the safety analysis. For all screen 
fail subjects, the Investigator or designee will complete Case Report Forms related to the 
completed visits and a Study Exit Form. 
3.6 Primary Effectiveness Analysis 
The primary effectiveness analysis is an exact binomial test to evaluate whether the observed 
response rate is significantly larger than 40% after the first 3 months of the Treatment Period.  The 
analysis will be performed on the ITT population.  Subjects who do not complete at least 10 days of 
diary data at the 3-month time point and who do not continue in the study will be classified as 
treatment non-responders. 
 
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The number and proportion of treatment responders, and its 95% confidence interval, using exact 
(Clopper-Pearson) confidence limits, will be presented.  A p-value for the one-sided upper-tail test 
of whether the proportion is significantly larger than 0.40, will also be presented. 
 
The null hypothesis will be rejected if a sufficient percentage of subjects exhibit treatment response at 
the 3 month time point. 
3.7 Secondary Effectiveness Analyses 
The primary effectiveness analysis will be repeated for the 3, 6 month and 12 month time points on 
the PP population. 
 
Changes from baseline will be evaluated at the 3, 6, 9 and 12 month time points, for the following 
effectiveness measures, also on the PP population: 
 
- 
St. Mark’s (Vaizey) Incontinence Severity Score 
- 
FIQOL questionnaire subscales 
 
PGI-I scores at 3, 6, 9 and 12 months (assessment not done at Baseline)  
3.8 Additional Analyses 
The change from baseline in the average (mean) number of FI episodes per week, and percent 
change from baseline, will be evaluated at the 3, 6, and 12 month time points.  Negative values 
represent a decrease in the number of episodes (i.e., improvement), while positive values represent 
an increase in the number of episodes. 
 
The change from baseline in the average (mean) number of FI days per week, and percent change 
from baseline, will be evaluated at the 3, 6, and 12 month time points.  Negative values represent a 
decrease in the number of days (i.e., improvement), while positive values represent an increase in 
the number of days. 
  
A cost analysis comparing the Eclipse System to other available therapies will also be performed. 
This will be described in a separate Statistical Analysis Plan. 
3.9 Subgroup Analyses 
The primary and secondary analyses will be repeated on the subgroups of < 65 years of age and   
≥ 65 years of age. 
3.10  Safety Analyses 
The number of overall adverse events will be summarized using the Medical Dictionary for 
Regulatory Activities (MedDRA) system organ class and preferred term and listings will be reviewed 
at regular intervals by the CEC.  Device-related adverse events, and device-related serious adverse 
events occurring at each time point will be summarized. The CEC adjudicated AEs will be utilized in 
the safety endpoint analyses 
3.11 Power and Sample Size Considerations 
Power calculations were performed based on the primary effectiveness analysis, which tests 
whether the fraction of treatment responders is significantly greater than 0.40 (H0: π ≤ 0.40 vs. HA: 
π > 0.40) using a one-sided exact binomial test, based on significance α = 0.025 and power 1 – β = 
0.90.  
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Based on the LIFE study, we anticipate an 85.6% success rate among study completers and 
conservatively estimate 21.3% dropout within 3 months, resulting in an estimated 67% response 
rate in this study.  With as few as 40 subjects in the ITT cohort, the study has ≥90% power to detect 
a response rate greater than 40%. Additional subjects, up to the maximum of 150 subjects, will be 
enrolled through a specified end date in order to provide a more robust analysis. 
Withdrawal from the study during the Screening Period is estimated to be quite high due to the 
baseline diary completion and device fitting requirements. Subjects who are successfully fit with the 
Eclipse System and successfully complete the Screening Period will be eligible for treatment. 
Therefore, an estimated 160 to 600 subjects may be recruited into this study in order to achieve 40 
to 150 subjects who successfully enter the Treatment Period.   
We estimate the subject dropout rate between the start of the Treatment Period and the 12 month 
visit to be 33%, yielding approximately 25 to 100 subjects completing 12 months of study 
participation.  In a 12 month study of non-surgical management of stress urinary incontinence the 
dropout rate over this same time period was approximately 36%.29    
 
4 Adverse Events 
Investigators and the Sponsor will carefully track and report adverse events.  Any subject who is exposed 
to the Eclipse System, including the Eclipse Insert, the Trial Insert or Sizers (has any Eclipse System device 
inserted into their vagina) will be included in the Safety Cohort and Safety Endpoint Analysis.  
Adverse event definitions are provided in Table 4.  Based on clinical experience to date the expectation is 
a very low risk of serious or unanticipated device-related adverse events.  
Table 4. Adverse Event Categories 
Term 
Definition 
Adverse 
event (AE) 
Any untoward medical occurrence, unintended disease or injury, or untoward clinical signs 
(including abnormal laboratory findings) in subjects, users or other persons, whether or not 
related to the investigational medical device. This definition includes events related to the 
study device and events related to any involved procedures.  
Serious 
adverse 
event (SAE) 
Any AE that 
• 
led to a death, 
• 
led to a serious deterioration in the health of the subject that: 
o 
resulted in a life-threatening illness or injury 
o 
resulted in a permanent impairment of a body structure or a body function 
o 
required hospitalization or prolongation of existing hospitalization* 
o 
resulted in medical or surgical intervention to prevent permanent impairment to 
body structure or function, or to prevent one of the other outcomes (e.g. 
bronchospasm requiring treatment in an emergency room 
o 
led to fetal distress, fetal death, a congenital abnormality, or birth defect 
 
Note that a planned hospitalization for a pre-existing condition, or a procedure required by the clinical 
investigational plan, without a serious deterioration in health, is not considered to be an SAE.  Note also 
that continuation of permanent disability (e.g. failure of the Eclipse Insert to improve FI) is not considered 
an SAE. 
29 Richter, et al. non-surgical management of stress urinary incontinence: ambulatory treatments for leakage associated with stress 
(ATLAS) trial. Clinical Trials 2007; 4: 92-101. 
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Term 
Definition 
Unanticipated 
adverse 
device effect 
(UADE) 
Any serious adverse effect on health or safety or any life-threatening problem or death caused 
by, or associated with, a device, if that effect, problem, or death was not previously identified 
in nature, severity, or degree of incidence in the investigational plan or application (including a 
supplementary plan or application), or any other unanticipated serious problem associated 
with a device that relates to the rights, safety, or welfare of subjects.30  
* For purposes of defining a serious adverse event, hospitalization is defined as admission to the 
hospital for longer than 24 hours or prolongation of a hospital stay due to the adverse event. 
4.1 Adverse Event Severity 
The investigator will be asked to characterize the severity of each AE as mild, moderate or severe 
according to definitions provided in Table 5.   
Table 5. Adverse Event Severities 
Term 
Definition 
Mild 
The AE is transient and easily tolerated by the subject. 
Moderate 
The AE causes the subject discomfort, interrupts the subject’s usual activities and 
requires a visit to a healthcare practitioner. 
Severe 
The AE causes considerable interference with the subject’s usual activities; may be 
incapacitating and may require hospitalization. 
4.2 Adverse Event Association 
The relationship of all AEs to the Eclipse System will be reported on the Case Report Forms by the 
site investigator according to the definitions provided in Table 6. Any devices associated with SAEs 
will be returned in order to facilitate product investigations. Devices associated with non-serious 
adverse events may also be returned, at the direction of the Sponsor, to assist with product 
investigations. 
Table 6. Adverse Event Relationship to Device 
Term 
Definition 
Definite 
Adverse event whose timing is highly plausible for causality and which cannot be 
explained by other factors 
Probable 
Adverse event whose timing is reasonable for causality and is unlikely to be explained 
by other factors 
Unlikely 
Adverse event whose timing is unlikely for causality and which could be explained by 
other factors 
Not related 
Adverse event whose timing makes causality improbable and which could easily be 
explained by other factors 
Unknown 
Adverse event whose plausibility of timing cannot be judged or in which information 
regarding other factors does not exist 
4.3 Adverse Event Reporting 
Any AEs that occur after a subject has been fit with an Eclipse System device will be recorded on the 
AE case report form. Pre-existing medical conditions will not be reported as AEs unless there is an 
increase in severity or frequency of symptoms. All AEs should be followed until they are either 
resolved or considered by the clinician to be stable or until the subject exits the study and is no longer 
available for follow up. Relevant source documentation must be available to confirm the occurrence 
of an AE and must be provided to the Sponsor upon request. 
30 21 CFR 812.3(s)  
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4.3.1 
Adverse Event Coding 
All adverse events will be monitored by the Sponsor on an ongoing basis, and checked against the 
MedDRA coding dictionary for consistency, which will be described in detail in the Data 
Management Plan.  
4.3.2 
Clinical Events Committee 
A Clinical Events Committee (CEC), comprised of a Medical Monitor and a CEC Chair, will be 
responsible for the safety oversight of the Trial. The members will be licensed and board certified 
physicians with experience in female pelvic medicine and reconstructive surgery, including 
Urogynecology and Obstetrics and Gynecology. They will have experience treating female fecal 
incontinence and with the functional mechanism of the Eclipse System. Experience as a PI or Sub-
Investigator in one or more previous multi-center FI trials is also a pre-requisite. However, they will 
not be affiliated with an enrolling site in the LIBERATE Trial. Additionally, the CEC members are 
required to declare any/all conflicts of interest to the Sponsor (as they arise) throughout the duration 
of the trial. 
4.3.3 
CEC Adjudication of AEs 
The CEC Medical Monitor will review listings of all Sponsor-coded AEs at regular intervals to 
determine if any clarifications or coding changes are required, or if any additional information is 
needed in order to make a determination regarding the relationship of an AE to any of the Eclipse 
System devices.  All device-related Serious AEs (SAEs) and Unanticipated Adverse Device Effects 
(UADEs) will be reviewed by the CEC Chair in a timely manner; all other AEs will be reviewed at 
monthly and quarterly meetings, as per the CEC Charter. 
A summary of all AEs will be provided to the CEC Chair for approval prior to results being utilized 
in the safety endpoint analyses. 
4.3.4 
SAE Reporting 
All serious adverse events (SAEs) must be reported to the Sponsor within 48 hours of becoming 
aware of the event, and to the governing IRB per their reporting requirements. The site must 
maintain detailed information, including copies of de-identified source documents pertaining to the 
event, on file and provide them to the Sponsor upon request for Medical Monitor review and Clinical 
Events Committee adjudication.  
The Sponsor will review all AEs suspected of being an SAE per Table 4 and will ensure any 
necessary reporting of the event(s) to investigators and reviewing IRBs as necessary. 
4.3.5 
UADE Reporting 
Unanticipated adverse device effects (UADEs) must be reported to the Sponsor within 48 hours 
after becoming aware of the event.  The site must maintain detailed information, including copies 
of de-identified source documents pertaining to the event, on file and provide them to the Sponsor 
upon request for Medical Monitor review and Clinical Events Committee adjudication. In addition, 
UADEs should be reported to the governing IRB within the timelines required by the IRB. 
The study Sponsor will immediately conduct an evaluation of any unanticipated adverse device 
effect (21 CFR 812.46(b)) and will ensure the necessary reporting of the event(s) to investigators 
and reviewing IRBs within 10 working days of the Sponsor first becoming aware of the event. If an 
investigation shows that an unanticipated adverse device effect presents an unreasonable risk to 
subjects, the Sponsor will terminate the investigation or parts of the investigation presenting that 
risk as soon as possible. Termination will occur no later than 5 working days after the Sponsor 
makes this determination and no later than 15 working days after the Sponsor first receives notice 
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of the effect (21 CFR 812.46(b)(2)).  The Sponsor will only resume the investigation after obtaining 
IRB, and if necessary, FDA approval (21 CFR 812.150(c)). 
5 Study Management 
Pelvalon, Inc. is the Sponsor of this clinical investigational plan.  The LIBERATE study is proposed by the 
Sponsor as a non-significant risk (NSR) study (see Section 5.2.1).  Investigational device exemption (IDE) 
approval from US FDA is not required for an NSR study provided that the reviewing IRBs agree with the 
NSR designation.  NSR studies follow the abbreviated requirements listed in 21 CFR 812.231.  These 
requirements are summarized in Table 7 and described in more detail below. 
Table 7. Abbreviated Requirements for NSR Device Investigations 
Labeling per 21 CFR 812.5 
IRB approval with NSR determination  
Informed consent per 21 CFR 50 
Study Monitoring per 21 CFR 812.46 
Investigator Recordkeeping per 21 CFR 812.140 (a) (3) (i) 
Sponsor Recordkeeping per 21 CFR 812.140(b) (4) and (5) 
Investigator Reports required per 21 CFR 812.150 (a) (1), (2), (5), and (7) 
Sponsor Reports required per 21 CFR 812.150(b)(1)-(3), (5)-(10) 
Prohibition against promotion per 21 CFR 812.7 
5.1 Investigational Device Labeling 
As per 21 CFR 812.5, the study device packaging includes a label with all required elements, 
including the statement: “CAUTION – Investigational device.  Limited by United States law to 
investigational use.” In addition, the IFU describes all relevant contraindications, hazards, adverse 
events, interfering substances, warnings, and/or precautions. 
5.2 IRB Approval  
Consistent with 21 CFR 56, this clinical protocol and a site-specific informed consent form will be 
submitted to the local or regional IRB and must be approved by each investigator’s IRB before the 
investigator may enroll subjects. 
This study is proposed as a non-significant risk (NSR) clinical study with regulatory oversight 
managed by the IRBs of participating centers in the United States. Refer to the Sponsor’s Statement 
of Non-Significant Risk below in Section 5.2.1.   
5.2.1 
Sponsor Statement of Non-significant Risk 
Requirements for NSR studies are described by the FDA in 21 CFR 812 and a corresponding 
guidance document.32 Devices are categorized as either “significant risk” or “non-significant risk.”  
A device is classified as non-significant risk if it does not meet the criteria of significant risk as 
defined below: 
According to 21CFR§812.3(m) Significant risk device means an investigational device that: 
31 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=812&showFR=1 
 
 
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 (1) Is intended as an implant and presents a potential for serious risk to the health, safety, or 
welfare of a subject;  
(2) Is purported or represented to be for a use in supporting or sustaining human life and 
presents a potential for serious risk to the health, safety, or welfare of a subject;  
(3) Is for a use of substantial importance in diagnosing, curing, mitigating, or treating disease, 
or otherwise preventing impairment of human health and presents a potential for serious risk 
to the health, safety, or welfare of a subject; or  
(4) Otherwise presents a potential for serious risk to the health, safety, or welfare of a 
subject. 
 
Pelvalon believes the Eclipse™ System does not meet any of the above criteria, and is therefore a 
non-significant risk device.  Referencing 21CFR§812.3(m) above: 
(1) The Eclipse System is not an implant.  It can be rapidly removed by the wearer.    
(2) The insert does not support or sustain human life. 
(3) The insert, in this application, is not of substantial importance in diagnosing, curing, 
mitigating or treating disease. While it may be of substantial importance in  preventing 
impairment of human health by treatment of fecal incontinence, based on clinical evidence 
from several prior studies, it does not present a potential for serious risk to the health, safety, 
or welfare of the subject. 
(4) The study design does not introduce any procedures which are experimental.  Vaginal 
inserts such as diaphragms and pessaries are commonly used for a range of gynecologic 
and female health conditions.  Furthermore, the insert may be removed either by the patient 
or the physician at any time.   
 
As with all prior Pelvalon studies, this study is proposed as a non-significant risk (NSR) clinical study. 
As detailed in Section 1.6 “Prior Investigations”, previous studies of the Eclipse System were granted 
NSR status by all participating site IRBs. Also, FDA is aware of the NSR status of the prior studies 
and did not disagree with that designation. As a non-significant risk study, this study does not require 
submission and approval of an investigational device exemption (IDE) from FDA. 
5.3 Informed Consent 
Investigators will use a study-specific informed consent form which is consistent with regulatory 
requirements in 21 CFR 50, and will be approved by the governing IRB prior to use.  The consent 
form template, found in Appendix 1 should be used as a template for each participating site’s 
consent.  The final consent form must be reviewed by the Sponsor prior to submission to the 
reviewing IRB, and a copy of the IRB approved version must be provided to the Sponsor prior to use 
in the study. 
5.4 Monitoring 
The study will be monitored per 21 CFR 812.46 according to the procedures outlined in Section 
5.8.4. 
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5.5 Recordkeeping  
The Sponsor will ensure that the Investigator maintains the following records including the minimum 
requirements in Table 7 for 21 CFR 812.140(a)(3)(i): 
 
(3) Records of each subject's case history and exposure to the device. Case histories include the 
case report forms and supporting data including, for example, signed and dated consent 
forms and medical records including, for example, progress notes of the physician, the 
individual's hospital chart(s), and the nurses' notes. Such records shall include: 
i. 
Documents evidencing informed consent and, for any use of a device by the 
investigator without informed consent, any written concurrence of a licensed 
physician and a brief description of the circumstances justifying the failure to obtain 
informed consent. The case history for each individual shall document that informed 
consent was obtained prior to participation in the study. 
 
The Sponsor will maintain the following records as required per 812.140(b)(4) and (5): 
 
(4) The following records, consolidated in one location and available for FDA inspection and 
copying: 
- 
The name and intended use of the device and the objectives of the investigation. 
- 
A brief explanation of why the device is not a significant risk device. 
- 
The name and address of each investigator. 
- 
The name and address of each IRB that has reviewed the investigation. 
- 
A statement of the extent to which the good manufacturing practice regulation in 21 
CFR Part 820 will be followed in manufacturing the device.  
a. Any other information required by FDA. 
(5) Records concerning adverse device effects (whether anticipated or unanticipated) and 
complaints. 
5.5.1 
Record Retention 
Investigators and Sponsor shall maintain study records for a period of 2 years after the latter of the 
following two dates: The date on which the investigation is terminated or completed, or the date 
that records are no longer required for purposes of supporting FDA marketing approval, or such 
longer period as required by applicable law. 
5.6 Reports  
The investigator will prepare and submit the following complete, accurate, and timely reports as 
required per 812.150(a)(1) (2) (5) and (7):  
 
(1) Unanticipated adverse device effects. An investigator shall submit to the sponsor and to the 
reviewing IRB a report of any unanticipated adverse device effect occurring during an 
investigation as soon as possible, but in no event later than 10 working days after the investigator 
first learns of the effect. 
(2) Withdrawal of IRB approval. An investigator shall report to the sponsor, within 5 working days, a 
withdrawal of approval by the reviewing IRB of the investigator's part of an investigation. 
(5) Informed consent. If an investigator uses a device without obtaining informed consent, the 
investigator shall report such use to the sponsor and the reviewing IRB within 5 working days 
after the use occurs. 
(7) Other. An investigator shall, upon request by a reviewing IRB or FDA, provide accurate, 
complete, and current information about any aspect of the investigation. 
 
The sponsor shall prepare and submit the following complete, accurate, and timely reports as 
required per 812.150(b)(1)-(3) and (5)-(10): 
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(1) Unanticipated adverse device effects. A sponsor who conducts an evaluation of an unanticipated 
adverse device effect under 812.46(b) shall report the results of such evaluation to FDA and to 
all reviewing IRB's and participating investigators within 10 working days after the sponsor first 
receives notice of the effect. Thereafter the sponsor shall submit such additional reports 
concerning the effect as FDA requests. 
(2) Withdrawal of IRB approval. A sponsor shall notify FDA and all reviewing IRB's and participating 
investigators of any withdrawal of approval of an investigation or a part of an investigation by a 
reviewing IRB within 5 working days after receipt of the withdrawal of approval. 
(3) Withdrawal of FDA approval. A sponsor shall notify all reviewing IRB's and participating 
investigators of any withdrawal of FDA approval of the investigation, and shall do so within 5 
working days after receipt of notice of the withdrawal of approval. 
(5) Progress reports. At regular intervals, and at least yearly, a sponsor shall submit progress reports 
to all reviewing IRB's.  
(6) Recall and device disposition. A sponsor shall notify FDA and all reviewing IRB's of any request 
that an investigator return, repair, or otherwise dispose of any units of a device. Such notice shall 
occur within 30 working days after the request is made and shall state why the request was made. 
(7) Final report. In the case of a device that is not a significant risk device, the sponsor shall submit 
a final report to all reviewing IRB's within 6 months after termination or completion. 
(8) Informed consent. A sponsor shall submit to FDA a copy of any report by an investigator under 
paragraph (a)(5) of this section of use of a device without obtaining informed consent, within 5 
working days of receipt of notice of such use. 
(9) Significant risk device determinations. If an IRB determines that a device is a significant risk 
device, and the sponsor had proposed that the IRB consider the device not to be a significant 
risk device, the sponsor shall submit to FDA a report of the IRB's determination within 5 working 
days after the sponsor first learns of the IRB's determination. 
(10) Other. A sponsor shall, upon request by a reviewing IRB or FDA, provide accurate, complete, 
and current information about any aspect of the investigation. 
5.7 Additional Investigator Responsibilities 
The site Principal Investigator (PI) is responsible for the entire oversight and day-to-day conduct of 
the investigation and for ensuring that the investigation is conducted according to all signed 
agreements, the Clinical Investigational Plan, all applicable regulatory requirements and the 
principles embodied within the Declaration of Helsinki, and any conditions of approval imposed by 
the IRB.  The site PI is also responsible for maintaining control of the investigational devices, and for 
protecting the rights, safety and welfare of subjects under the investigator’s care and for obtaining 
informed consent in accordance with 21 CFR Part 50.   
Additional responsibilities of the Investigator include, but are not limited to: 
 
• 
Maintaining records of receipt, use or disposition of a device that relate to: 
- 
The type and quantity of the device, the dates of its receipt, and the lot number. 
- 
The names of all persons who received, used, or disposed of each device. 
- 
Why and how many units of the device are returned to the sponsor, or are otherwise 
disposed of. 
• 
Maintaining subjects records of all relevant observations, including adverse device effects 
(whether anticipated or unanticipated), information and data on the condition of each subject 
upon entering, and during the course of, the investigation, including information about 
relevant previous medical history and the results of all diagnostic tests. 
• 
Maintaining records of dates and reasons for each deviation from the protocol. 
• 
Ensuring that IRB approval is obtained prior the participation of a subject in a clinical trial.  
Such participation includes obtaining written informed consent. 
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• 
Ensuring that the Investigational device is used only under the supervision of an appropriately 
trained and qualified clinician. 
• 
Returning or disposing of the study supplies at the Sponsor’s written request. 
• 
Ensuring that all personnel assisting with the clinical trial are adequately informed and 
understand their trial-related duties and functions. 
 
Each site should identify a study coordinator for this study.  Working with, and under the authority of 
the site PI, the study coordinator assures that all study requirements are fulfilled, and is the contact 
person at the site for all aspects of study administration.   
Each Investigator must allow direct access to source data/documents for trial related monitoring, 
audit, IRB review and FDA inspection, if needed.  Also, the investigator must allow auditing of their 
clinical investigational procedure(s). 
5.7.1 
Device Storage and Accountability 
The investigational Eclipse System components will be stored at room temperature at the 
Investigational Site in a secure location with access limited to study personnel.  Any unused devices 
will be returned to the Sponsor at the completion of the investigational site’s participation in the 
study.  Sponsor may request used Trial Inserts (used during the screening period) to be returned 
to Pelvalon. All used Eclipse Inserts (used during the treatment period) must be returned to the 
Sponsor at the termination of a subject’s participation. All used Inserts must be returned using 
biohazard packaging materials and labels supplied by the Sponsor, or disposed of at the site at the 
direction of the Sponsor. The Investigator must maintain records of the receipt and disposition of 
all devices.  A record of the devices used by each subject should be maintained in the subject’s 
record (CRF and source document).  
5.7.2 
Product Non-conformities and/or User Feedback 
The site is responsible for returning used devices (considered bio-hazardous materials) or unused 
devices that are either non-conforming, related to a potential product malfunction, related to an 
SAE, or at the direction of the Sponsor, in order to facilitate any necessary product investigations. 
The Sponsor will provide written instructions for reporting of the non-conformity and/or user 
feedback, and all necessary materials, including biohazard labels, required for returning these 
devices to the Sponsor. The site is expected to cooperate with the Sponsor to gather all relevant 
information in any investigations initiated as a result of a non-conformity or user feedback report. 
5.7.3 
Investigator Records 
Investigator record requirements are described above in Sections 5.5 and 5.6.  In addition, the 
investigator will maintain original source documents from which study-related data are derived, 
which include, but are not limited to: 
 
• 
Clinic progress notes recording subject’s medical history and medications 
• 
Medical records regarding AEs, including treatment and clinical outcome  
• 
Records of non-study related assessments or interventions, such as results of diagnostic 
tests, and any hospitalizations 
• 
Notes of phone calls and/or correspondence indicating investigational site’s attempts to follow 
study subjects at the required follow-up visits until subject’s participation in the study is 
complete or terminated 
• 
Records relating to subject death (e.g., death certificate, autopsy report/terminal medical 
records) 
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5.8 Sponsor Responsibilities 
Pelvalon, Inc. is the manufacturer of the Eclipse System and Sponsor of this study.  The Sponsor’s 
recordkeeping and reporting responsibilities per 21 CFR 812 are described in Sections 5.5 and 5.6.  
Additional responsibilities include site qualification, site initiation and training, interim monitoring, and 
close out of the study at participating sites. 
5.8.1 
Site Qualification 
The Sponsor will review investigator qualifications for study participation by site visit or phone call, 
as needed to determine site suitability for the study.  Sites will be evaluated to confirm adequate 
trained and experienced staff (in general clinical research procedures and the therapeutic area), 
including a designated study coordinator, and facilities to perform the study according to the 
requirements of the protocol, as well as an adequate subject population. 
5.8.2 
Site Initiation and Training  
Prior to enrolling any subjects a site initiation visit will be conducted to confirm the site continues to 
be able to meet the requirements of the trial.  All investigators, device fitters and study coordinators 
will undergo study-specific training prior to or during a Site Initiation Visit, to review the 
Investigator/site responsibilities and requirements for the study. These include but are not limited 
to: 
 
• 
Device use training for clinicians who are fitting the device 
• 
Instructions for Use (IFU) 
• 
Subject Use and Care Instructions 
• 
Clinical Investigational Plan (CIP) 
• 
Regulatory files 
• 
Consenting procedures, including the protection of subject confidentiality 
• 
IRB reporting requirements  
• 
Data entry procedures and guidelines, which may include training in use of an Electronic 
Data Capture (EDC) system 
• 
Device accountability and storage procedures 
 
Site personnel training will be documented and all study training records will be maintained by the 
Sponsor. 
5.8.3 
Site Authorization to Enroll 
Sites will be notified in writing by the Sponsor when screening, recruitment and enrollment of 
subjects may begin. An Authorization to Enroll letter will be sent from the Sponsor to the PI and 
Study Coordinator once the following minimum requirements have been met: 
 
• 
CV and medical license is on file for PI  
• 
Clinical Investigational Plan (CIP) Signature Page, signed by the PI, is on file 
• 
Signed Investigator Agreement is on file for PI 
• 
The IRB approval of the investigational plan and informed consent form are on file 
• 
Clinical Trial Agreement between the Site and the Sponsor is fully executed  
• 
Site initiation and training visit is completed and the required training records are on file 
 
Under no circumstances should a site begin recruiting subjects for the study without written 
authorization to do so from the IRB and the Sponsor. 
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5.8.4 
Interim Monitoring 
Periodic site monitoring visits will be performed during the study by a designated study monitor 
assigned by the sponsor.  The purpose of routine monitoring visits is to confirm compliance to the 
protocol, continued site acceptability in terms personnel staffing and resources, to ensure 
compliance with the IRB requirements, such as the use of only approved versions of the informed 
consent form, and to ensure accurate and complete records are being maintained and that CRFs 
are completed in an accurate and timely manner.  
The initial monitoring visit to a site will be scheduled soon after the first 2 to 5 subjects are enrolled 
in the study.  The frequency of subsequent visits will be dependent upon the rate of enrollment and 
site performance on previous monitoring visits.  
Monitoring of the study will be a continuous process conducted in accordance with 21 CFR 812.46 
and applicable Sponsor procedures.  Monitoring will be performed by qualified Sponsor clinical 
research personnel, or designees (contract CRAs).  The monitors will follow the procedures 
described within the Monitoring Plan, briefly summarized below: 
• 
Monitors will be qualified by training and experience and may be Sponsor representatives or 
contractors. 
• 
Remote monitoring of electronic Case Report Forms will occur on an ongoing basis as part of 
the routine data review and data management activities. Queries will be issued, reviewed and 
resolved within the electronic data capture (EDC) system on an ongoing basis. Remote 
monitoring may also be done via review of faxed/scanned diaries, questionnaires, CRFs, and 
de-identified source documents.  
• 
Onsite monitoring of source documentation, the regulatory binder and device accountability 
records will occur at regular intervals as subject enrollment and data volume dictates, according 
to the Monitoring Plan, but no less than once during the trial and again at the end of the trial.  
• 
Monitors will ensure the appropriate reporting of protocol deviations, AEs, SAEs, and UADEs 
within the case report forms, to the Sponsor and to the governing IRB. 
• 
Monitors will facilitate the requests for, and transmission of, de-identified source documents 
from the site to the Sponsor, as requested for Medical Monitor review and adjudication of 
Adverse Events or to support investigations of product non-conformance or complaints. 
• 
If there are significant non-compliance issues at a site, including lack of adherence to the 
protocol or applicable regulatory requirements, the issues will be discussed with the 
Investigator and study coordinator and the site will be instructed on how to regain compliance. 
• 
Noncompliance with the signed agreement, the investigational plan, or other applicable 
regulatory requirements, will be communicated by the monitor to the Sponsor’s study 
management team, and will be documented in the monitoring report and the follow up letter. 
The monitor and the Sponsor’s study management team will work with the site to secure 
compliance through corrective and preventive action (CAPA) planning and documentation, as 
necessary. 
• 
In cases of serious or repeated nonconformance the Sponsor may either temporarily or 
permanently discontinue shipments of the investigational devices to the site, or temporarily or 
permanently put the site “on hold” for screening and enrolling new subjects. All subjects 
currently enrolled will continue to be followed as per the protocol until they can be appropriately 
exited from the study.  
• 
The Sponsor will also ensure that investigators return any unused devices, unless this action 
would jeopardize the rights, safety, or welfare of a subject. 
5.8.5 
Site Close-out  
At the completion of the last follow-up visit at each site a close-out visit will be performed. At the 
discretion of the Sponsor, the close out visit may be conducted remotely. The reasons for deciding 
to conduct a remote close out visit will be transmitted in writing to the applicable site(s) and may 
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include low subject enrollment, or cases where all CRFs have been previously monitored. The 
purpose of the Close-out Visit is to: 
• 
Reconcile all outstanding data queries 
• 
Review the records retention requirements for the study as per Section 5.5.1 
• 
Arrange for the return of all study materials to the Sponsor 
• 
Review the final IRB requirements for the study 
5.9 Protection of Confidentiality 
At all times throughout the clinical investigation, confidentiality will be observed by all parties involved.  
All data will be secured against unauthorized access.  Privacy and confidentiality of information about 
each subject will be preserved in study reports and in any publication.  Each subject participating in 
this study will be assigned a unique identifier.  All CRFs will be tracked, evaluated, and stored using 
only this unique identifier.   
Each site Principal Investigator will maintain a confidential study subject list identifying all enrolled 
subjects. This list will contain the assigned study subject’s unique identifier and name.  The 
investigator bears responsibility for keeping this list confidential.  This list will not be provided to the 
study Sponsor and is only to be used at the study center. 
Monitors and auditors will have access to the study subject list and other personally identifying 
information of study subjects to ensure that data reported in the CRF corresponds to the person who 
signed the ICF and the information contained in the original source documents.  Such personal 
identifying information may include, but is not limited to the subject’s name, address, date of birth, 
gender, race and medical record number.   
NOTE: The subject’s name, medical record number or address will NOT be recorded in the monitor’s 
visit report or the database; demographic data that may be recorded include date of birth, race, and 
gender.   
Source documents copied for monitoring purposes by the Sponsor will be identified by using the 
assigned subject’s unique identifier in order to protect subject confidentiality. 
The data collected about each subject, and the results of this study, belong to the Sponsor and may 
be used for business purposes such as in publications, marketing materials, or regulatory 
submissions. An IRB-approved HIPAA authorization is required to be signed by each subject before 
their data can be used in the study and their medical records monitored.  
5.10 Trial Registration 
This trial will be registered on clinicaltrials.gov website.  As this device is not yet cleared for 
commercialization, the publication of study results on the clinicaltrials.gov website will be delayed 
under the terms of US Public Law 110-85, Title VIII, Section 801. 
5.11 Data Collection and Data Management 
Study data will be collected using standardized case report forms that may be either paper-based or 
electronic. If electronic, the electronic data capture (EDC) system will be validated and verified as 21 
CFR Part 11 compliant.  Sites will be trained in completion of CRFs and the use of the EDC system 
prior to being issued access to the system.   
The Sponsor is responsible for the design and user acceptance testing of the database, and for 
routine data review, monitoring (remotely and onsite), and query resolution. 
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5.12 Protocol Deviations 
A protocol deviation is defined as any study action taken by study-associated personnel or subjects 
that is in conflict with the study protocol.  All protocol deviations will be documented in the site files, 
and on the appropriate case report form(s).   
The investigator should notify the Sponsor and the IRB immediately if any protocol deviation was 
necessary in order to protect the life or physical well-being of a subject in an emergency. All protocol 
deviations should be reported to the governing IRB according to the IRB’s requirements.  
5.13 Study Suspension or Early Termination 
The study may be discontinued at the discretion of the Sponsor either at an individual site or at all 
sites for reasons including, but not limited to, the following: 
• 
Occurrence of unexpected adverse events or unanticipated adverse device effects 
• 
New scientific information that shows that the study is no longer valid or necessary 
• 
Insufficient recruitment of subjects 
• 
Persistent non-compliance with the protocol 
• 
Persistent non-compliance with IRB or regulatory requirements 
• 
Business reasons 
 
If the study is discontinued or suspended prematurely, the Sponsor will promptly notify the following 
in writing of the termination or suspension and the reason(s) for it: 
• 
All clinical investigator(s)/investigational center(s) 
• 
All governing central IRBs 
 
If the study is discontinued or suspended prematurely, the Investigator(s) will promptly notify the 
following in writing of the termination or suspension and the reason(s) for it: 
• 
Their governing local IRBs 
• 
The subjects and/or their primary care physicians if deemed necessary by the governing IRB 
or the Sponsor   
5.14 Final Report 
A final report will be completed, even if the study is prematurely terminated.  At the conclusion of the 
trial, a multi-center abstract reporting study results may be prepared.  The publication of results from 
any single center experience within the trial is not allowed until the aggregate study results have been 
published, unless there is written consent from the Sponsor.  
6 Risk Analysis  
It is anticipated that the risks and benefits of the Eclipse System are comparable to vaginal devices, such 
as pessaries, currently marketed for gynecologic care.  Risks to the subject are minimized by use under 
the care and instruction of the investigator, regular study visits and because subjects may remove the 
device at any time as needed.  Subjects may experience a change in bowel or urinary habits while using 
the device.  Common side effects related to poor hygiene with the use of vaginal devices are malodorous 
odor, vaginal discharge and itching.  Subjects will be advised to maintain proper hygiene, and on the use 
and care of the Eclipse System (Appendix 9). 
Anticipated risks associated with the use of the Eclipse System, as seen in the previous clinical evaluations, 
include: 
• 
Pelvic Cramping or Discomfort 
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• 
Pelvic Pain 
• 
Vaginal Erythema / Petechiae 
• 
Vaginal Discharge 
• 
Vaginal Abrasion 
• 
Vaginal Bleeding 
• 
Vaginal Spotting 
• 
Vaginal Ecchymosis or Bruising 
• 
Vaginal Irritation 
• 
Yeast Infection (Candidiasis) 
• 
Lower Urinary Tract Infection 
• 
Urinary Incontinence 
• 
Urinary Urgency / Frequency 
• 
Difficulty with Urinary Voiding 
• 
Difficulty with Stool Evacuation 
 
Refer to the IFU (Appendix 8) for a list of warnings and precautions. 
It is possible that any of these risks or discomforts may occur with greater frequency or severity than 
previously reported.  It is also possible that there are risks that are unknown at this time. As detailed in the 
background section, previous clinical evaluations of the Eclipse System in over 200 subjects support the 
low-risk nature of the device and that the risk profile is similar to the risks anticipated with other vaginal 
devices.   
 
 
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7 Abbreviations 
 
Abbreviation 
Meaning 
ABL 
Accidental Bowel Leakage 
AE 
Adverse Event 
CAPA 
corrective and preventive action plan 
CEC 
Clinical Events Committee 
CFR 
Code of Federal Regulations 
CIP 
Clinical Investigational Plan 
CRA 
Clinical Research Associate 
CRF 
Case Report Form 
EDC 
Electronic Data Capture 
e-stim 
electric stimulation 
FDA 
Food and Drug Administration 
FI 
Fecal Incontinence 
FIQOL 
Fecal Incontinence Quality of Life 
H0 
null hypothesis 
HA 
alternate hypothesis 
IBD 
Irritable Bowel Disease 
IDE 
Investigational Device Exemption 
IFU 
Instructions for Use 
IRB 
Institutional Review Board 
ITT 
Intent to Treat 
MedDRA 
Medical Dictionary for Regulatory Activities 
mmHG 
millimeters of Mercury 
MMHQ 
Modified Manchester Health Questionnaire 
NSR 
Non-significant Risk 
PGI-I 
Patient Global Impression of Improvement 
PP 
Per Protocol 
PTNS 
Percutaneous Tibial Nerve Stimulation 
SAE 
Serious Adverse Event 
SNS 
Sacral Nerve Stimulation 
UADE 
Unanticipated Adverse Device Effect 
US 
United States 
UTI  
Urinary Tract Infection 
VBC 
Vaginal Bowel Control 
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8 Revision Record  
 
 
Section 
Description of Change 
Rev C – 10 Dec 2015 
Rev D – 09 Feb 2017 
Protocol 
Synopsis 
Clarified that enrollment may 
be up to 150 subjects. 
150 treatment-eligible subjects will be 
enrolled into the 12 month Treatment 
Period at up to 15 clinical sites in the 
United States 
Up to 150 treatment-eligible subjects may 
be enrolled into the 12 month Treatment 
Period at up to 15 clinical sites in the United 
States 
Table of 
Contents 
Updated page numbers. 
NA 
NA 
2.2 Target 
Population 
Clarified that enrollment may 
be up to 150 subjects. 
Removed statement that half 
of subjects enrolled will be 65 
or older. 
It is anticipated that up to 625 subjects 
may need to be screened and consented 
to yield 150 subjects entering the 
Treatment Period for the effectiveness 
analysis. 
Safety will be evaluated based on all 
subjects who undergo fitting with the 
Eclipse System. Recruitment will be 
managed to ensure approximately one 
half of the subjects who enter the 
Treatment Period are age 65 and older. 
It is anticipated that up to 625 subjects may 
need to be screened and consented to yield 
up to 150 subjects entering the Treatment 
Period for the effectiveness analysis. 
Safety will be evaluated based on all 
subjects who undergo fitting with the 
Eclipse System. 
2.3 Recruitment 
Clarified that enrollment may 
be stopped or paused at any 
time by the Sponsor. Revised 
individual site enrollment 
contribution levels from a 
number cap to a percent of 
total launched. Removed 
statement that enrollment 
may be restricted by sub-
group. 
Each site is expected to enroll a minimum 
of 10 and a maximum of 30 treatment-
eligible subjects...Enrollment is 
competitive until overall enrollment target 
is reached, and recruitment may be 
restricted by sub- groups to ensure 
approximately one half of the subjects 
entering the Treatment Period are <65 
years of age and one half are >65 years 
of age. 
Each site is expected to contribute 
approximately 7-25% of the total treatment-
eligible subjects...Enrollment is competitive 
until overall enrollment target is reached or 
study termination by the Sponsor. 
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Section 
Description of Change 
Rev C – 10 Dec 2015 
Rev D – 09 Feb 2017 
3.6 Primary 
Effectiveness 
Analysis 
Removed references to 
absolute enrollment numbers 
to reflect potential interim 
analyses. 
The null hypothesis will be rejected if 
72/150 of subjects exhibit treatment 
response at the 3 month time point. 
The null hypothesis will be rejected if a 
sufficient percentage of subjects exhibit 
treatment response at the 3 month time point.  
3.11 
Power 
and Sample 
Size 
Considerations 
Added in ranges based on 
revised enrollment and power 
estimates. Removed power 
estimates for non-primary 
endpoints. 
Based on the LIFE study, we anticipate 
an 85.6% success rate among study 
completers and conservatively estimate 
21.3% dropout within 3 months, resulting 
in an estimated 67% response rate in this 
study.  With 150 subjects in the ITT 
cohort, the study has >90% power to 
detect a response rate greater than 40%.   
Withdrawal from the study during the 
Screening Period is estimated to be quite 
high due to the baseline diary completion 
and device fitting requirements. Subjects 
who are successfully fit with the Eclipse 
System and successfully complete the 
Screening Period will be eligible for 
treatment. Therefore, an estimated 625 
subjects may be recruited into this study in 
order to achieve 150 subjects who 
successfully enter the Treatment Period.   
We estimate the subject dropout rate 
between the start of the Treatment Period 
and the 12 month visit to be 33%, yielding 
100 subjects completing 12 months of 
study participation.  In a 12 month study 
of non-surgical management of stress 
urinary incontinence the dropout rate over 
this same time period was approximately 
Based on the LIFE study, we anticipate an 
85.6% success rate among study 
completers and conservatively estimate 
21.3% dropout within 3 months, resulting in 
an estimated 67% response rate in this 
study.  With as few as 40 subjects in the ITT 
cohort, the study has ≥90% power to detect 
a response rate greater than 40%. 
Additional subjects, up to the maximum of 
150 subjects, will be enrolled through a 
specified end date in order to provide a 
more robust analysis.   
Withdrawal from the study during the 
Screening Period is estimated to be quite 
high due to the baseline diary completion 
and device fitting requirements. Subjects 
who are successfully fit with the Eclipse 
System and successfully complete the 
Screening Period will be eligible for 
treatment. Therefore, an estimated 160 to 
600 subjects may be recruited into this study 
in order to achieve 40 to 150 subjects who 
successfully enter the Treatment Period.   
We estimate the subject dropout rate 
between the start of the Treatment Period 
and the 12 month visit to be 33%, yielding 
approximately 25 to 100 subjects 
completing 12 months of study participation.  
In a 12 month study of non-surgical 
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Section 
Description of Change 
Rev C – 10 Dec 2015 
Rev D – 09 Feb 2017 
36%.33 The study has a 90% power to 
detect a response rate greater than 40% 
at 12 months. 
management of stress urinary incontinence 
the dropout rate over this same time period 
was approximately 36%. 
NA 
Minor clarifications and edits 
to spelling throughout 
Protocol. 
NA 
NA 
 
 
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9 Appendices 
 
 
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Appendix 1 – Informed Consent Form Template 
[Incorporated by reference behind this cover sheet] 
 
 
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Appendix 2 – FI Episode Sample Diaries 
[Incorporated by reference behind this cover sheet] 
 
 
 
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Appendix 3 – FIQOL Questionnaire 
[Incorporated by reference behind this cover sheet] 
 
 
 
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Appendix 4 – PGI-I Questionnaire 
[Incorporated by reference behind this cover sheet] 
 
 
 
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Appendix 5 – Patient Goal Questionnaire 
[Incorporated by reference behind this cover sheet] 
 
 
 
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Appendix 6 - Device Satisfaction Questionnaire 
[Incorporated by reference behind this cover sheet] 
 
 
 
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Appendix 7 – FI Information Brochure 
[Incorporated by reference behind this cover sheet] 
 
 
 
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Appendix 8 – Eclipse System Instructions for Use 
[Incorporated by reference behind this cover sheet] 
 
 
 
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Appendix 9 – Eclipse System Use and Care Instructions for LIBERATE Study Subjects 
[Incorporated by reference behind this cover sheet] 
 
 
 
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Appendix 10 – Cost Utilization Survey 
[Incorporated by reference behind this cover sheet] 
 
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