LIBERATE - PRO: An Extended Use Registry to Further Develop Understanding of the Long Term Use of the Eclipse™ System for Fecal Incontinence in Women Via Patient Reported Outcomes
Conditions: Fecal Incontinence, Bowel Dysfunction, Bowel Incontinence, Accidental Bowel Leakage
Sponsor: Pelvalon, Inc.

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Clinical Investigational Plan 
 
PURSUIT:  
A Registry to Further Develop the Understanding of the 
Real World use of the Eclipse™ System for Fecal 
Incontinence in Women  
 
Protocol: CA007 
Revision: B 
27 Dec 19 
 
 
 
 
 
 
 
 
Study Sponsor: 
Pelvalon, Inc. 
2880 Lakeside Dr. Ste 201 
Santa Clara, CA 95054 
 
 
 
 
 

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PURSUIT Protocol Synopsis 
Study 
Objective 
A Registry to Further Develop the Understanding of the Real World use of the 
Eclipse™ System for Fecal Incontinence in Women 
Study 
Design 
A prospective, open label post-market registry to collect Patient Reported Outcomes 
and Fitting metrics (e.g. sizes used) in subjects using the Eclipse System in a 
commercial setting 
Sites/ 
Subjects 
Up to 400 subjects enrolled, in up to 25 sites 
Study 
Population 
All adult female patients with Fecal Incontinence who present at, or are identified at, 
participating sites are eligible. This includes patients who are newly prescribed 
Eclipse, and those already using Eclipse who return for an annual renewal visit during 
the enrollment period. 
Study 
Duration  
Per-patient registry participation will last one year from the date of Eclipse fitting. Sites 
will be allowed to enroll patients until the earlier of: 12/31/2021 or enrollment of 400 
patients.  
Outcomes 
Measures 
1. Fitting Metrics 
2. Change from baseline in mean scores on subject-reported outcomes related to 
symptoms as reported by St. Mark’s (Vaizey) Incontinence Severity Score 
3. Eclipse Experience Feedback Assessment, including the Patient Global 
Impression of Improvement (PGI-I) 
Eligibility 
Criteria 
1. Adult female 
2. Diagnosis of Fecal Incontinence 
3. Clinician recommendation of the Eclipse System 
4. Subject provides informed consent and HIPAA authorization  
 
 
 
 
 
 
 
 
 

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Table of Contents 
 
1 
Background ..................................................................................................................................... 5 
1.1 
Feasibility Studies ............................................................................................................................................................... 5 
1.2 
LIFE Pivotal Study ............................................................................................................................................................... 5 
1.3 
LIBERATE........................................................................................................................................................................... 5 
1.4 
LIBERATE PRO .................................................................................................................................................................. 5 
1.5 
Description of the Eclipse System ....................................................................................................................................... 6 
1.5.1 
Overview ...............................................................................................................................................................................................6 
1.5.2 
The Sizing Kit ........................................................................................................................................................................................6 
1.5.3 
The Trial Insert ......................................................................................................................................................................................6 
1.5.4 
The Eclipse Insert .................................................................................................................................................................................6 
1.5.5 
The Pump ..............................................................................................................................................................................................7 
1.6 
Mechanism of Action of the Eclipse System ........................................................................................................................ 8 
1.7 
Regulatory Status of the Eclipse System ............................................................................................................................. 9 
1.8 
Indications for Use .............................................................................................................................................................. 9 
2 
Current Study Description ............................................................................................................. 9 
2.1 
Study Design ....................................................................................................................................................................... 9 
2.2 
Target Population ................................................................................................................................................................ 9 
2.3 
Recruitment and Enrollment ................................................................................................................................................ 9 
2.4 
Schedule of Events ........................................................................................................................................................... 10 
2.5 
Surveys ............................................................................................................................................................................. 11 
2.5.1 
Bowel Health History .......................................................................................................................................................................... 11 
2.5.2 
Fitting Metrics ..................................................................................................................................................................................... 11 
2.5.3 
Eclipse Experience Assessment ........................................................................................................................................................ 11 
2.5.4 
St. Marks (Vaizey) Incontinence Severity Score ............................................................................................................................... 11 
2.5.5 
Optional 3, 6 and 9 Month Surveys.................................................................................................................................................... 12 
3 
Statistics ........................................................................................................................................ 12 
3.1 
Statistical Analysis Plan .................................................................................................................................................... 12 
3.2 
Analysis Population ........................................................................................................................................................... 12 
3.3 
Outcomes Measurements ................................................................................................................................................. 12 
4 
Other Study Details ....................................................................................................................... 13 
4.1 
Device Related Injuries and Product Complaints ............................................................................................................... 13 
4.2 
IRB Approval ..................................................................................................................................................................... 13 
4.3 
Informed Consent .............................................................................................................................................................. 13 
4.4 
Monitoring ......................................................................................................................................................................... 13 
 
The study does not require on-site monitoring (See Section 2.1), but data will be reviewed on an ongoing basis and sites 
and/or subjects may be contacted by phone, email, or in writing to provide clarification of discrepant or missing data. ................. 13 
4.5 
Recordkeeping and Record Retention ............................................................................................................................... 13 
4.6 
Reports ............................................................................................................................................................................. 13 
4.7 
Protection of Confidentiality ............................................................................................................................................... 14 
4.8 
Trial Registration ............................................................................................................................................................... 14 
4.9 
Data Collection and Data Management ............................................................................................................................. 14 
4.10 
Compensation to Patients ................................................................................................................................................. 15 
4.11 
Study Termination ............................................................................................................................................................. 15 
4.12 
Final Report ...................................................................................................................................................................... 15 
5 
Benefits and Risks ........................................................................................................................ 15 
5.1 
Benefits ............................................................................................................................................................................. 15 
5.2 
Risks ................................................................................................................................................................................. 15 
5.3 
Other Risks of the Device .................................................................................................................................................. 15 
6 
Revision Record ............................................................................................................................ 17 
 
List of Figures 
List of FiguresList of Figures 
4............................................................................................................... 3 
Figure 1. Eclipse Insert (inflated state) 
7 ................................................................................................... 3 
Figure 2. Pump 
7 ..................................................................................................................................... 3 
Figure 3. Insert; deflated (left), and inflated (right) 
8 .................................................................................. 3 
Figure 4. Deflated balloon 
9 ....................................................................................................................... 4 
Figure 5. Folded Insert 
9 ............................................................................................................................ 4 
Table 1. Regulators and Associated Pressures 
7 ...................................................................................... 4 
Table 2. Schedule of Events 
10 ................................................................................................................. 4 
Figure 1. Eclipse Insert (inflated state) ......................................................................................................... 7 
Figure 2. Pump .............................................................................................................................................. 7 
Figure 3. Insert; deflated (left), and inflated (right) ........................................................................................ 8 

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Figure 4. Deflated balloon ............................................................................................................................. 9 
Figure 5. Folded Insert .................................................................................................................................. 9 
 
List of Tables 
Table 1. Regulators and Associated Pressures ............................................................................................ 8 
Table 2. Schedule of Events ....................................................................................................................... 11 
 
 
 

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1 Background 
1.1 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. Initial safety and effectiveness outcomes were deemed acceptable for 
ongoing study.  
1.2 LIFE Pivotal Study 
The LIFE Study (Protocol CA003) was a multi-center, prospective, open label clinical trial 
conducted at 6 centers in the United States. As with the prior studies, all IRBs approved the trial as 
an NSR investigation. 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.   
Sixty-one (61) subjects met all study eligibility criteria and entered the 1-month Treatment Period to 
make up the Intent to Treat Cohort. The primary effectiveness endpoint was met: At 1 month, 
78.7% of the ITT Cohort (95% CI, 66-88%, p<0.0001) met the success criterion, defined as a 50% 
or more reduction in the number of FI episodes. Additionally, there were no serious device-related 
adverse events reported in the trial.  
1.3 LIBERATE 
The LIBERATE study was a multi-center, prospective, open label clinical trial conducted at 11 
centers in the United States. As with the prior studies, all IRBs approved the trial as an NSR 
investigation. The objective of this study was to evaluate the safety and effectiveness among 
treatment responders between 3 and 12 months. 
Seventy-three (73) subjects met all study eligibility criteria and entered the 12-month Treatment 
Period to make up the Intent to Treat Cohort. The primary effectiveness endpoint was met: At 3 
months, 73% (95% CI 61-82%, p<.0001) of subjects met the success criterion, deined as a 50% or 
more reduction in the number of FI episodes. At 12 months, 70% (95% CI 58-80%, p < 0.0001) met 
the success criterion. Additionally, throughout the study there were no serious device-related 
adverse events reported. 
1.4 LIBERATE PRO 
The LIBERATE PRO registry study is an on-going, prospective, open label post-market registry to 
collect patient reported outcomes in subjects using the Eclipse System after completing the 
LIBERATE study. Patients who completed LIBERATE were offered new Eclipse devices to be used 
in the subsequent year, and were offered enrollment in LIBERATE PRO in which they would 
complete online surveys at 3, 6, 9, and 12 months.. As the registry database was hosted and 
maintained by Pelvalon (sponser) and no clinic visits were required of the patients, Pelvalon was 
the only site to seek and obtain IRB approval. 
 
Eighteen (18) patients enrolled in the registry and completed one or more surverys. All but 2 
patients have completed their participation and there have been no adverse events reported as 
part of LIBERATE PRO. 

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1.5 Description of the Eclipse System 
1.5.1 
Overview 
The Eclipse System is a vaginal bowel control (VBC) therapy intended to provide bowel control for 
women with fecal incontinence. Manufactured by Pelvalon (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. 
1.5.2 
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). 
1.5.3 
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 use 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. 
1.5.4 
The Eclipse Insert 
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. The Eclipse Insert is graphically depicted in Figure 1. 
A silicone inflation tube connects to the balloon on one end, and to a self-closing 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. 

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Figure 1. Eclipse Insert (inflated state) 
1.5.5 
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 ports 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 with a 
Medium regulator attached. The Low and High Regulators may also be shipped separately. 
 
 
Figure 2. Pump 
 
 
 

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Table 1. Regulators and Associated Pressures 
 
Regulator 
Pressure at Full 
Inflation (mmHg) 
Low 
45-57 
Medium 
70-92 
High 
114-129 
1.6 Mechanism of Action of the Eclipse System 
The Insert is placed in a position similar to other vaginal devices, such as diaphragms, pessaries, 
and tampons, whose safety profiles are well-established.1,2,3 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) 
 
 
1 Lone et al. A 5 year prospective study of vaginal pessary use for pelvic organ prolapse. Int J Gynecol Obstet. 114 (2011) 56-59. 
2 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. 
3 Bash, et al. Review of vaginal pessaries. Obstetrical and Gynecological Survey (2000) 55, 7, p455-460. 

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Figure 4. Deflated balloon 
Figure 5. Folded Insert 
1.7 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. 
1.8 Indications for Use 
The Eclipse System is indicated for the treatment of fecal incontinence in adult women.  
2 Current Study Description 
2.1 Study Design 
PURSUIT is a prospective, open label post-market registry to collect Fitting metrics (e.g. sizes 
used) and Patient Reported Outcomes in subjects using the Eclipse System in a commercial 
setting.  
2.2 Target Population 
Up to 400 subjects may be enrolled. All women being approached for inclusion into the PURSUIT 
registry must be adult female patients at participating sites and must have a diagnosis of Fecal 
Incontinence. She must be a new user of Eclipse or a patient returning to the clinic for her annual 
f/u visit. All participants will be required to provide informed consent and HIPAA authorization. 
As the PURSUIT study does not have a pre-determined hypothesis or success end-point, the 
patient target population does not have a specific minimum and the 400 patient upper bound is 
based only on budgeting and resource availability. 
2.3 Recruitment and Enrollment 
All patients who are deemed new suitable clinical candidates for the Eclipse System at a 
participating site will be invited to participate, as well as patients who are already using Eclipse, and 
are due for their annual device replacement during the enrollment period (“renewal patients”).  
Potential subjects will be presented with information about how to sign up for the registry. Each 
subject will be directed to a study-specific URL (searchable web page) where they can read an 
electronic Informed Consent Form and HIPAA Authorization Form. If they click on the “I agree to 
participate”, “I consent”, or similarly worded button they are taken to a registration form and are 
asked to provide their full name, date of birth, address, phone number and email address. 

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By navigating to and completing the registration page, this signifies the subject’s willingness to 
participate in the online surveys and to receive future emails with the links to the online surveys to 
be completed, as well as to be contacted by the Sponsor by phone, email or in writing to remind 
them to complete the surveys, and/or to provide clarifications about the information they have been 
provided in the completed surveys. 
If a subject does not have access to, or is unwilling to provide, an email address, they can review a 
paper version of the Informed Consent Form and HIPAA Authorization form, and will be given an 
option to receive paper versions of all study surveys which can be filled out by hand and mailed 
back to the Sponsor. Similarly, if a site cannot easily access the URL, they can use the paper 
versions of all forms / surveys as well. 
Enrollment in the post market registry, including the online data capture, will last for up to one year, 
and recruitment will end on 12/31/2021 or after 400 patients have been enrolled.  
Sites will receive compensation for completing site surveys at each patient visit. Subjects will 
receive compensation for their time to complete each online (or returned hard copy) survey, which 
will be outlined in the Informed Consent form. 
 
Enrollment will be completed once the annual visit is complete (approximately 1 year after 
enrollment begins). 
 
In the case of renewal patients, if the patient is no longer local to the participating site and is due for 
a renewal device, the site PI may contact and evaluate the patient by phone or video.  If the site PI 
deems it clinically appropriate, she or her research staff may obtain the patient’s consent by 
directing her to the electronic consent form and presenting the appropriate information about the 
study.  If the patient agrees to the informed consent and registers for the study as described above, 
she will be enrolled, walked through the appropriate case report forms, and the site may ship the 
renewal device to the patient.  At the following annual renewal visit (approximately 1 year after 
enrollment), if the patient is unable to travel to the site, the PI or her research staff may again 
contact the patient by phone or video to evaluate her experience and ensure the appropriate case 
report forms are completed online. 
 
2.4 Schedule of Events 
At the Enrollment/Fitting visit, and subsequent in-office visits (as outlined below, in Table 2), 
patients and clinicians will access online surveys to complete the required data collection (or if 
necessary, use hard copies). Additionally, subjects will be sent an email with a link to the optional 3, 
6, and 9 month surveys or mailed printed surveys, depending on chosen survey delivery method, to 
be completed at each of 3, 6, and 9 month time points as per the schedule in Table 2.  
 
Note that renewal patients will not require “Subsequent fitting visits” or the “Eclipse Visit”, as they 
have been successfully fit prior to this registry study and are merely obtaining a replacement 
device.  As such, these visits can be omitted for these patients. 
 
For renewal patients who are no longer near their participating site and are unable to travel to the 
site, but who wish to renew their device and take part in the registry, they may be enrolled and their 
evaluations may be conducted by their respective PI over the phone, or by video, as described in 
section 2.3. 
 

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Table 2. Schedule of Events 
(shaded columns indicate in-office visits) 
 
Enrollment / Fitting 
Subsequent Fittings 
(if necessary) 
Eclipse Visit 
3 Mo 
6 Mo 
9 Mo 
12 Mo 
Informed Consent & HIPAA Authorization 
X 
 
 
 
 
 
 
Bowel Health History 
X 
 
 
 
 
 
 
Fitting Metrics 
X 
X 
X 
 
 
 
X 
St. Marks (Vaizey) Assessment 
X 
 
X 
X 
X 
X 
X 
Eclipse Experience Assessment (including PGI-I) 
 
X  
X 
X 
X 
X 
X 
2.5 Surveys 
The following questionnaires or surveys will be collected (as outlined in Table 2, above): 
2.5.1 
Bowel Health History 
The Bowel Health History survey collects information regarding the patient’s history with FI 
(symptoms and treatments), as well as other bowel health items, such as IBS and Rectal Prolapse. 
Also included are marketing questions about Eclipse and health insurance. 
2.5.2 
Fitting Metrics 
Clinicians will be asked at fitting visits, Eclipse visits, and annual renewals to provide information on 
the fitting process. For example, how many Inserts were used, and what sizes. 
2.5.3 
Eclipse Experience Assessment 
Subjects will be asked, at in-office visits (fitting follow-ups and 12-month visits), to provide feedback 
on several Eclipse Experience questions related to perceptions of device comfort, satisfaction with 
usage and features, and impact on daily activities. This assessment includes the Patient Global 
Impression of Improvement (PGI-I), 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). The PGI-I 
will be used to assess improvement of accidental bowel leakage in comparison to how it was prior 
to joining the registry or starting with Eclipse. 
2.5.4 
St. Marks (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.4,5,6 This score reflects the severity of FI and ranges from 0 (complete 
continence) to 24 (complete incontinence). 
 
 
4 Vaizey, CJ, et al Gut 1999;44:77-80 doi:10.1136/gut.44.1.77 
5 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. 

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2.5.5 
Optional 3, 6 and 9 Month Surveys  
For the completion of online surveys at interim timepoints, a single survey generated using Survey 
Monkey containing the Eclipse Experience Assessment and the Vaizey score will be sent to 
subjects via a secure e-mail link or letter for completion approximately every 3 months after 
registering for the study. The electronic surveys are designed in such a way that there is no way to 
link a specific computer’s IP address to the survey responses. For patients unable or unwilling to 
use the online survey, paper copies can be mailed to their addresses, with a pre-paid return 
envelope. 
Subjects will have a 4 week window during which they can complete the surveys (every 3 months 
+/- 2 weeks) from their Eclipse Fitting date (or renewal date). If the surveys for the associated time 
period are not completed within this 4 week window, they will be counted as missed data points. 
Subjects will receive at least one, and no more than 5, reminders (by email and/or mail) to complete 
the surveys throughout the 4 week window. 
3 Statistics 
3.1 Statistical Analysis Plan 
Data collected in the PURSUIT study is not intended to support product approval or to establish 
safety or effectiveness of the Eclipse System. There is therefore not a pre-determined hypothesis or 
success end-point, and a statistical analysis plan is not required. Any data from the study used to 
support Eclipse System marketing claims will be analyzed per Pelvalon’s quality system statistical 
procedures. 
3.2 Analysis Population 
The Analysis Data Set (ADS) will include all subjects who consent to participate in the PURSUIT 
registry and have at least an initial fitting, or, in the case of a patient already using Eclipse, be 
administered an annual renewal Eclipse. 
For any analyses that require a comparison to baseline data, or data collected at the initial fitting 
visit, patients who enroll at their Eclipse renewal will be omitted from the ADS, as they will not have 
baseline or fitting metrics. 
3.3 Outcomes Measurements 
Outcomes Measurements will be assessed at 12 months. Additional assessments may be made for 
interim (3, 6, 9-month) time points. Where applicable, changes from baseline will be evaluated. 
Baseline data will be defined as data provided at the initial Fitting Visit. If the patient was previously 
using the Eclipse System (e.g. joins the registry at a yearly follow-up/renewal), her baseline values 
will be omitted, and she will be excluded from analyses that require a baseline value. 
 
The PGI-I, assessed as part of the Eclipse Experience Assessment, assesses changes from 
baseline in the control of bowel leakage, but does not have a baseline measurement. Instead, it is 
rated on a 7-point scale, where 1 is “Very much better” and 7 is “Very much worse”. For a given 
time point, the average PGI-I score will be computed as the mean score across all completed 
assessments. Other Eclipse Experience Assessment questions will be summarized descriptively. 
 
 
 
6 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 

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Fitting Metrics will collected at the fitting visits, and summarized using descriptive statistics. 
 
4 Other Study Details 
4.1 Device Related Injuries and Product Complaints  
All device-related adverse events that result in serious injury will be summarized and tabulated 
based on the Medical Device Reporting (MDR) records maintained by Pelvalon, as required per 21 
CFR 803. Product complaints will be summarized and tabulated based on the product complaint 
records maintained by Pelvalon, as required per 21 CFR 820.198. 
 
As the study is not being carried out to establish product safety, a Clinical Events Committee is not 
required. As with any approved commercial product, patient safety will be monitored by each 
patient’s physician, and regulatory reporting will be handled by Pelvalon’s MDR and commercial 
complaint handling systems. 
4.2 IRB Approval  
Consistent with 21 CFR 56, and CFR 45 Part 160, and Subparts A and E of Part 164 (the 
Privacy Rule), this post market clinical study must be approved by an IRB prior to any subjects 
being enrolled. 
4.3 Informed Consent 
The Sponsor will use an electronic Informed Consent Form and HIPAA Authorization form which is 
consistent with regulatory requirements in 21 CFR 50 and 45 CFR 46, and will be approved by the 
governing IRB prior to use. If sites or patients are unable to unwilling to use the electronic forms, 
paper copies will be made available. 
4.4 Monitoring 
4.5 The study does not require on-site monitoring (See Section 2.1), but data will 
be reviewed on an ongoing basis and sites and/or subjects may be 
contacted by phone, email, or in writing to provide clarification of discrepant 
or missing data.Recordkeeping and Record Retention 
Pelvalon will maintain evidence via an electronic / digital audit trail that electronic informed consent 
and HIPAA authorization was obtained prior to PHI being collected. 
 
Pelvalon shall maintain study records for a minimum period of 2 years after the investigation is 
terminated or completed, or until the records are no longer required for purposes of supporting an 
FDA or International marketing approval, or such longer period as required by applicable law. 
4.6 Reports  
The site, with, or without Pelvalon’s assistance shall prepare and submit the following complete, 
accurate, and timely reports: 
 
• 
Progress reports. Pelvalon shall submit required progress reports to the reviewing IRB, as 
required by the IRB. 
• 
Final report. Pelvalon shall submit a final report to the reviewing IRB within 6 months after 
termination or completion of the study. 

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• 
Other. A sponsor shall, upon request by a reviewing IRB or FDA, provide accurate, complete, 
and current information about any aspect of the investigation. 
4.7 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, by limited access to the survey 
responses to the clinical research department personnel at Pelvalon. 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 surveys or extracts of data 
on the CRFs will be tracked, evaluated, and stored using this unique identifier.  
The online surveys are generated using an online survey company called Survey Monkey, and are 
designed without the ability to link the respondent’s IP address to the survey responses they 
submit. The responses are stored on Survey Monkey’s servers which are located in the United 
States. Survey Monkey has a privacy policy in place to protect the confidentiality of both the 
Sponsor (creator of the surveys used in this research study) and the respondents. Survey Monkey’s 
privacy policy can be found here: https://www.surveymonkey.com/mp/policy/privacy-policy/ 
Personal health information being collected in this registry dataset include the subject’s name, date 
of birth, address, phone number and email address. The responses to the surveys will be 
downloaded at regular intervals and will be maintained for ease of access and reference in a 
separate excel, pdf or other electronic file extract on a Pelvalon shared cloud-based application 
called Box. Pelvalon has a signed Business Associates Agreement (BAA) with Box. Pelvalon’s 
privacy policy can be found here: http://eclipsesystem.com/privacy-policy/  
The data collected about each subject, and the results of this study, belong to Pelvalon 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 collected and used for study purposes.  
4.8 Trial Registration 
This trial will be registered on clinicaltrials.gov website.  
4.9 Data Collection and Data Management 
Study data will be collected using surveys that are designed to be completed online. The survey 
questions will be built using an online survey tool called Survey Monkey. A secure link will be 
available to the clinician and patients for use during visits, and will be sent to each patient at the 
interim time points via email. In some cases, patients may be unable to complete the surveys 
electronically in which case they may be mailed to their home address with a pre-paid return 
envelope for them to complete and return the survey in hard copy format. If hard copy surveys are 
collected these will be data entered by either Pelvalon Clinical or other delegated representatives of 
Pelvalon, and the hard copy surveys will be maintained as part of the audit trail. 
Survey outputs will be confirmed to match inputs during initial system setup. These surveys are for 
testing only and will not be included in data. 
As the PURSUIT study is a registry study only, it does not have a separate data management plan. 
A minimum of 10% of all Survey Monkey responses will be compared to the Excel output to confirm 
accuracy. This frequency is sufficient given the low risk of the study and of data corruption. If errors 
are found, the review may be expanded for the specific question or site or both. 
Any corrections to collected data will be documented and rationale provided. 

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4.10 Compensation to Patients 
Patients will be compensated for data collection for any completed online surveys at any of the 3, 6, 
or 9-month time points. Additionally, patients may be compensated for their in-office visits, including 
the time it takes for them to complete the surveys in-office. The amounts to be provided to the 
patients will be stated in the Informed Consent.  
4.11 Study Termination 
The study may be discontinued at Pelvalon’s discretion for the following reasons: 
• 
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 subject non-compliance with survey completion 
• 
Business reasons 
 
If the study is discontinued or suspended prematurely, Pelvalon will notify all participating subjects 
and the IRB promptly. 
4.12 Final Report 
A final report will be completed, even if the study is prematurely terminated. The publication of the 
results will be at Pelvalon’s discretion, with the exception of required results posting to 
clinicaltrials.gov.  
5 Benefits and Risks  
5.1 Benefits 
The benefits of using the Eclipse System are that it is a self-managed, non-surgical device that may help 
a woman to control their accidental bowel leakage symptoms. It is possible that the Eclipse System may 
not provide any direct benefit to subjects in this research study. The information collected in this research 
study will help the company who manufactures the device to understand the longer term performance of 
the Eclipse System, which may benefit women who use this therapy in the future.  
5.2 Risks 
The main risk to being in this research study is a risk of sharing protected (personal) health information 
(PHI), and the potential breach of confidentiality. 
5.3 Other Risks of the Device 
The Eclipse System Patient Guide directs patients to report any of the following to their doctor if they 
occur: 
• 
Foul odor or excessive vaginal discharge 
• 
Difficulty urinating or defecating 
• 
Significant bleeding not associated with menstruation 
• 
New onset or worsening pelvic pain or discomfort 
 
Good hygiene is important for the safe use of any vaginal insert. Proper care and cleaning of the Insert is 
important to avoid common side effects related to poor hygiene such as infection, bad odor, vaginal 
discharge and itching. Proper cleaning should reduce the likelihood of these events.  

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Some women may experience some changes in their bowel or urinary habits while wearing the Insert. 
They may also experience some mild discomfort during the insertion and/or removal of the Eclipse Insert 
in the same manner that inserting a tampon, diaphragm or pessary can be uncomfortable.   
In previous clinical studies, over 200 women have worn the Insert with no serious device-related adverse 
events being reported. Non-serious adverse events that were reported include: 
• 
Pelvic Cramping or Discomfort 
• 
Pelvic Pain 
• 
Vaginal Erythema (redness) / Petechiae (a small red or purple spot caused by bleeding) 
• 
Vaginal Discharge 
• 
Vaginal Abrasion 
• 
Vaginal Bleeding 
• 
Vaginal Spotting 
• 
Vaginal Ecchymosis (bruising) 
• 
Vaginal Irritation 
• 
Yeast Infection (Candidiasis) 
• 
Lower Urinary Tract Infection 
• 
Urinary Incontinence 
• 
Urinary Urgency / Frequency 
• 
Difficulty with Urinary Voiding 
• 
Difficulty with Stool Evacuation 
 
The use of the study device in pregnant women has not been evaluated and may involve risks to you (or 
to an embryo or fetus, if you are, or may become pregnant).  
The safety and effectiveness of the Eclipse System have not been evaluated in women who use an IUD.  
There may also be risks to using the Eclipse Insert that are not known at this time. 
Warnings  
The Insert contains metal, so it must be removed before obtaining an MRI. An MRI may cause heating or 
movement of the Insert, which could lead to adverse events. 
Before obtaining a pelvic X-ray, women should consult with their physician about whether or not to 
remove the Insert as the Insert may obscure images.  
The Insert and the Pump are for single-patient use only, so should not be shared with anyone. Sharing 
the Insert and/or Pump could result in transmission of disease and/or infection. 
 
 
 
 

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6 Revision Record 
 
Document 
Revision 
Section amendment and rationale 
Protocol 
A 
Initial draft 
Protocol 
B 
Revised to clarify the nature of the study and study requirements. Updated Sponsor address. Extended 
enrollment period and number of potentially enrolled subjects. 
Clarified the visit schedule for renewal patients. 
Added the ability to remotely enroll renewal patients who are unable to travel to a participating site.