Effects of the Minnesota Medical Technologies Anal Insert Device in Fecal Incontinence
Phase: NA
Conditions: Fecal Incontinence
Sponsor: Minnesota Medical Technologies



 
 
ii 
ambulation, the subject would be allowed to immediately begin the fitting period using 
the 13mm device.   Updated primary endpoint language to clarify this process and align 
with study flow. 
 
Version 5.0 
Added notes to Schedule of Assessments in section 1.3 which were inadvertently removed in 
version 2. 
Version 6.0 
Added an assessment of the ability of subject to retain the device to the screening visit. 
Version 7.0 
Increase subject participation number for the 
 from 
 to 
. 

  
 
ii 
Table of Contents 
STATEMENT OF COMPLIANCE ............................................................................................................................. 1 
1.1 
Synopsis ................................................................................................................................................ 1 
1.2 
Schema ................................................................................................................................................. 7 
1.3 
Schedule of Activities (SoA) ............................................................................................................. 10 
2 
INTRODUCTION .......................................................................................................................................... 15 
2.1 
Study Rationale .................................................................................................................................. 15 
2.2 
Background......................................................................................................................................... 16 
2.3 
Risk/Benefit Assessment .................................................................................................................. 17 
2.3.1 
Known Potential Risks ................................................................................................... 17 
2.3.2 
Known Potential Benefits .............................................................................................. 18 
2.3.3 
Assessment of Potential Risks and Benefits .............................................................. 18 
3 
OBJECTIVES AND ENDPOINTS .............................................................................................................. 18 
4 
STUDY DESIGN ........................................................................................................................................... 23 
4.1 
Overall Design .................................................................................................................................... 23 
4.2 
Scientific Rationale for Study Design.............................................................................................. 24 
4.3 
Justification for TREATMENT .......................................................................................................... 24 
4.4 
End of Study Definition ..................................................................................................................... 25 
5 
STUDY POPULATION ................................................................................................................................ 25 
5.1 
Inclusion Criteria ................................................................................................................................ 25 
5.2 
Exclusion Criteria ............................................................................................................................... 26 
5.3 
Lifestyle Considerations .................................................................................................................... 27 
5.4 
Screen Failures .................................................................................................................................. 27 
5.5 
Strategies for Recruitment and Retention ...................................................................................... 28 
6 
STUDY INTERVENTION ............................................................................................................................ 28 
6.1 
Study Intervention(s) Administration ............................................................................................... 28 
6.1.1 
Study Intervention Description ..................................................................................... 28 
6.1.2 
DEVICE Administration ................................................................................................. 29 
6.2 
Preparation/Handling/Storage/Accountability ................................................................................ 30 
6.2.1 
Acquisition and accountability ...................................................................................... 30 
6.2.2 
Formulation, Appearance, Packaging, and Labeling ................................................ 31 
6.2.3 
Product Storage and Stability ....................................................................................... 31 
6.2.4 
Preparation ...................................................................................................................... 31 
6.3 
Measures to Minimize Bias: Randomization and Blinding ........................................................... 32 
6.4 
Study Intervention Compliance ........................................................................................................ 32 
6.5 
Concomitant Therapy ........................................................................................................................ 32 
6.5.1 
Rescue Medicine ............................................................................................................ 33 
6.6 
Discontinuation of Study Intervention ............................................................................................. 33 
6.7 
Participant Discontinuation/Withdrawal from the Study ............................................................... 34 
6.8 
Lost to Follow-Up ............................................................................................................................... 34 
7 
STUDY ASSESSMENTS AND PROCEDURES ..................................................................................... 35 
7.1 
SAFETY AND Efficacy Assessments ............................................................................................. 35 
7.2 
Safety and Other Assessments ....................................................................................................... 41 
7.3 
Adverse Events and Serious Adverse Events ............................................................................... 41 
7.3.1 
Definition of Adverse Events (AE) ............................................................................... 41 
7.3.2 
Definition of Serious Adverse Events (SAE) .............................................................. 41 
7.3.3 
Classification of an Adverse Event .............................................................................. 42 

  
 
iii 
7.3.4 
Time Period and Frequency for Event Assessment and Follow-Up ....................... 43 
7.3.5 
Adverse Event Reporting .............................................................................................. 44 
7.3.6 
Reporting Unanticipated Problems Involving Risks to Subjects or Others 
(UPIRTSOs) 
44 
7.3.7 
Reporting Events to Participants ................................................................................. 46 
7.3.8 
Events of Special Interest ............................................................................................. 46 
7.3.9 
Reporting of Pregnancy ................................................................................................ 46 
7.4 
Unanticipated Problems .................................................................................................................... 46 
7.4.1 
Definition of ANTICIPATED AND Unanticipated ADVERSE EVENTS, 
uNANTICIPATED PROBLEM (UP) ................................................................................................................ 46 
7.4.2 
Unanticipated Problem Reporting ................................................................................ 47 
7.4.3 
Reporting Unanticipated Problems to Participants ................................................... 47 
8 
STATISTICAL CONSIDERATIONS .......................................................................................................... 47 
8.1 
Statistical Hypotheses ....................................................................................................................... 48 
8.2 
Sample Size Determination .............................................................................................................. 49 
8.3 
Populations for Analyses .................................................................................................................. 50 
8.4 
Statistical Analyses............................................................................................................................ 50 
8.4.1 
General Approach .......................................................................................................... 50 
8.4.2 
Analysis of the Primary and secondary Efficacy Endpoint(s) .................................. 51 
8.4.3 
Analysis of the Secondary Endpoint(s) ....................................................................... 52 
8.4.4 
Safety Analyses .............................................................................................................. 52 
8.4.5 
Baseline Descriptive Statistics ..................................................................................... 52 
8.4.6 
Planned Interim Analyses ............................................................................................. 53 
8.4.7 
Sub-Group Analyses ..................................................................................................... 53 
8.4.8 
Tabulation of Individual subject Data .......................................................................... 53 
8.4.9 
Exploratory STUDY AND Analyses ............................................................................. 53 
9 
SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS .............................. 54 
9.1 
Regulatory, Ethical, and Study Oversight Considerations ........................................................... 54 
9.1.1 
Informed Consent Process ........................................................................................... 54 
9.1.2 
Study Discontinuation and Closure ............................................................................. 54 
9.1.3 
Confidentiality and Privacy ........................................................................................... 55 
9.1.4 
Future Use of 
 and Data ............................................................... 55 
9.1.5 
Key Roles and Study Governance .............................................................................. 56 
9.1.6 
Safety Oversight ............................................................................................................. 56 
9.1.7 
Clinical Monitoring .......................................................................................................... 56 
9.1.8 
Quality Assurance and Quality Control ....................................................................... 57 
9.1.9 
Data Handling and Record Keeping ............................................................................ 57 
9.1.10 
Protocol Deviations ........................................................................................................ 59 
9.1.11 
Publication and Data Sharing Policy ........................................................................... 59 
9.1.12 
Conflict of Interest Policy .............................................................................................. 59 
9.2 
Additional Considerations ................................................................................................................. 59 
9.3 
Abbreviations ...................................................................................................................................... 61 
9.4 
Protocol Amendment History ........................................................................................................... 63 
10 
REFERENCES ............................................................................................................................................. 64 
 

Effects of the Minnesota Medical Technologies Anal Insert Device in Fecal Incontinence 
 
 
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STATEMENT OF COMPLIANCE 
 
(1) [The trial will be carried out in accordance with the following:  
 
• 
United States (US) Code of Federal Regulations (CFR) applicable to clinical studies 21 CFR 
Parts 11, 50, 54, 56, and applicable sections of Part 812.  
 
The protocol, informed consent form(s), recruitment materials, and all subject materials will be 
submitted to the Institutional Review Board (IRB) for review and approval.  Approval of both the 
protocol and the consent form must be obtained before any subject is enrolled.  Any 
amendment to the protocol will require review and approval by the IRB before the changes are 
implemented to the study.  In addition, all changes to the consent form will be IRB-approved; a 
determination will be made regarding whether subjects previously enrolled will be required to 
re-consent.  
 
 
PROTOCOL SUMMARY 
1.1 
SYNOPSIS  
Title: 
Effects of the Minnesota Medical Technologies Anal Insert Device in Fecal 
Incontinence 
Study Description: 
This is a prospective, open label study during which subjects with Fecal 
Incontinence (FI) will be recruited and enrolled into the treatment group.  
Subjects will participate in a 4-week baseline period in which information 
on fecal incontinence, bowel habits, and global measures will be collected.   
 
Subjects meeting all inclusion and no exclusion criteria (including diary 
compliance, ≥ 4 FI episodes during the 4-week baseline period) will 
proceed to a up to  4-week fitting period where subjects will evaluate 
which of two device sizes (10mm or 13mm) is preferred.  At the screening 
visit, the 10 mm, and, if necessary thereafter, the 13 mm device will be 
inserted into the rectum to determine if the device stays in situ while 
subjects are ambulating.  Subjects who can retain the device will proceed 
to the baseline period.  Subjects who can retain neither device size will be 
withdrawn from the study.  After completion of the baseline period, those 
subjects who did not retain the 10 mm but did retain the 13 mm device 
will begin the fitting period with the 13 mm device.  The sequence of 
events for the fitting period will be as follows: 
1) Subjects who begin with the 10 mm device will use the device for 
a minimum of 2 weeks during the fitting period.  Subjects will be 
asked to complete daily bowel diaries  to determine the percent 
reduction in FI episodes, and subject comfort will be assessed 
using question #7 on the QUEST questionnaire.  If greater than or 
equal to 75% reduction in FI episodes is observed during this 
fitting period, the subject will proceed immediately to the 

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treatment period and will continue using the 10mm device for the 
entire treatment period.      If the reduction in FI episodes is less 
than 75%, and the QUEST score is 1-2 (indicating dissatisfaction 
with comfort), the subject will proceed immediately to the 
treatment period and will continue using the 10mm device for the 
entire treatment period.   If the reduction in FI episodes is less 
than 75%, and the QUEST score is 3-5 (indicating satisfaction with 
comfort), the participant will use 13 mm devices for a minimum of 
2 weeks as their fitting period and complete daily bowel diaries.  
At the end of this fitting period, the subject comfort will be 
reassessed with question #7 of the QUEST questionnaire.  Subjects 
who report QUEST scores of 1-2 (indicating dissatisfaction with 
comfort) with the 13mm device will use the 10mm device for the 
entire treatment period.  However, subjects who report QUEST 
scores of 3-5 (indicating satisfaction with comfort) at the end of 
the fitting period will proceed immediately to the treatment 
period and will continue using the size 13mm device for the entire 
treatment period. 
2)
Subjects who begin with the 13mm device will use the device for a
minimum of two weeks during the fitting period.  Thereafter, the
subject will proceed to the treatment period and will continue
using the 13mm device for the entire treatment period.
Following the fitting period, all subjects will then proceed to a 4-week 
treatment period in which information on fecal incontinence, bowel 
habits, and global measures will be collected. 
After the treatment period, all individuals who withdraw for reasons other 
than personal preference (i.e., for medical reasons) and a minimum of 50% 
of all patients shall undergo an evaluation by anoscopy following the 
treatment period to assess for device related trauma. 
The information on fecal incontinence, bowel habits, global measures and 
adverse events obtained during the bowel diary study (4-week baseline 
period and the 4-week treatment period) will be used to evaluate the 
safety and effectiveness of the study device.  Adverse events will be 
collected from enrollment through study exit. 
After completing baseline diaries, the following assessments will be 
performed for informational purposes:  1) All subjects who qualify for 
treatment with the Minnesota Medical Technologies Anal Insert will 
undergo a baseline anoscopy, 
 and 
.  2) Up to 
 subjects 
who qualify for treatment with the Minnesota Medical Technologies Anal 
Insert will undergo 
 testing with the 

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baseline. 
- 
The proportion of subjects in whom the device will reduce the volume 
of FI during the treatment period as compared to baseline. 
- 
The proportion of subjects in whom the anal insert device  reduces the 
proportion of FI episodes which are associated with diarrhea. 
- 
The proportion of subjects in whom the anal insert device reduces the 
number of episodes of passive and of urge FI. 
- 
The proportion of subjects in whom the anal insert device improves 
the Quality of Life (QOL) related to FI during treatment as compared to 
baseline. 
- 
The proportion of subjects in whom the anal insert device will affect 
the composition of stool leakage during treatment as compared to 
baseline. 
- 
The proportion of subjects are satisfied with the anal insert device. 
- 
The time for which a bowel movement can be deferred after the 
occurrence of urgency will be affected by the anal insert device. 
- 
The proportion of complete bowel movements will be affected by the 
anal insert device during treatment as compared to baseline. 
- 
Treatment with the anal insert device will affect anxiety and 
depression during treatment as compared to baseline. 
- 
The anal insert device reduces the use of medications for FI during 
treatment as compared to baseline. 
 
Exploratory Endpoints: 
-  Evaluate in up to 
 subjects the effects of the Minnesota 
Medical Technologies Anal Insert Device on 
 
. 
-  Evaluate if the effects of the Minnesota Medical Technologies Anal Insert 
Device on symptoms of FI 
 
 
 of the Minnesota Medical Technologies Anal 
Insert device to prevent anal leakage. 
-  Subjects 
 
 Minnesota Medical Technologies Anal Insert 
Device during 
.    
-  Evaluate the 
 in subjects with FI 
-  Investigate 
 associated with FI 
through 
 at baseline. 
 
Study Population: 
Male and female subjects aged 18 years and older with a diagnosis of fecal 

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incontinence who have failed conservative medical therapy (i.e., the use of 
bulking agents, anti-diarrheal agents (e.g., loperamide) and biofeedback 
therapy as appropriate) for FI.   
Phase: 
N/A 
Description of 
Sites/Facilities Enrolling 
Subjects: 
A single-site study at Mayo Clinic Rochester 
Description of Study 
Intervention: 
This Minnesota Medical Technologies Anal Insert Device is a non-sterile 
soft, flexible, liquid-filled anal insert meant for single use only (see Figures 
below).  The device is self-inserted into the anal canal where the liquid-
filled bulb of the device is designed to rest against, conform to, and 
provide a seal at the anorectal junction to prevent fecal discharge from the 
rectum.  The liquid-filled shaft of the device is designed to conform to and 
fill the anal canal allowing the pressure from the internal and external anal 
sphincters to seal the canal.  The device’s external retainer flare is 
designed to rest against the outside of the anus and prevents migration of 
the insert into the anal canal and rectum.  These mechanisms are designed 
to work together to prevent the involuntary leakage of fecal matter 
through the anal canal. 
The Minnesota Medical Technologies Anal Insert Device is depicted in 
Figure 1 below.  The profile drawing indicates the main parts of the device.  
The cross-section drawing shows the open lumen which allows for the 
insertion of the applicator.  It also shows the liquid-filled (mineral oil) bulb.  
This liquid-filled feature extends from the bulb, along the length of the 
device shaft, and onto the external retainer.  
Figure 1:  Main Parts of The Minnesota Medical Technologies Anal Insert 
Device 

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1.2 
SCHEMA 
 
 
 
 
 
be used for study analysis.  There will be a 4-week baseline period 
followed by an approximately 2 to 4-week fitting period, followed by a 
four (4) week treatment period.  Subjects will also be contacted by 
telephone to encourage compliance and to assess adverse events.  
Individual study participation is anticipated to be complete 4 weeks after 
the last day the device is used.   After the treatment period, all individuals 
who withdraw for reasons other than personal preference (i.e., for medical 
reasons) and a minimum of 50% of all patients shall undergo an evaluation 
by anoscopy following the treatment period to assess for device related 
trauma 
While the protocol intends the fitting period to follow directly the baseline 
period, if needed for scheduling, there can be up to a 7-day interval 
between the completion of the baseline and initiation of the fitting period.  
In addition, all study procedures can be performed at ± 7 days to 
accommodate scheduling issues.  
Subject Duration: 
The study will consist of a screening visit, a 4-week baseline period, an 
assessment visit, a 2 to 4-week fitting period, and a 4-week (28-days) 
treatment period.  Allowing for additional days to accommodate 
scheduling, including repeat anoscopy, if required, the subject 
participation duration is expected to be approximately 20 weeks.   
 
 

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, 
 (if not already performed as 
within six (6) months of consent), and 
).   
    
sub-study subjects (up to 
subjects who agree to 
 sub-study) will also have 
 
evaluate the effects of the Minnesota Medical Technologies Anal Insert Device on 
 
, and to evaluate
 
  Participants will be enrolled in 
this sub-study until up to 
participants have completed 
 sub-study.  In the event a subject does 
not wish to participate in 
 sub-study, but they do wish to participate in the treatment study, they 
may do so.  If they do not wish to participate in the treatment study, their participation in the trial will 
be terminated and they will exit the study.   
4. Eligible subjects will proceed to the fitting period which will last up to 4 weeks.   
Subjects who did not retain the 10 mm but did retain the 13 mm device at the screening visit will begin 
the fitting period with the 13 mm device.  The sequence of events for the fitting period will be as 
follows: 
1) Subjects who begin with the 10 mm device will use the device for a minimum of 2 weeks during 
the fitting period.  Subjects will be asked to complete daily bowel diaries to determine the 
percent reduction in FI episodes, and subject comfort will be assessed using question #7 on the 
QUEST questionnaire.  (a) If greater than or equal to 75% reduction in FI episodes is observed 
during this fitting period, the subject will proceed immediately to the treatment period and will 
continue using the 10mm device for the entire treatment period.  (b) If the reduction in FI 
episodes is less than 75%, and the QUEST score is 1-2 (indicating dissatisfaction with comfort), 
the subject will proceed immediately to the treatment period and will continue using the 10mm 
device for the entire treatment period.  (c) If the reduction in FI episodes is less than 75%, and 
the QUEST score is 3-5 (indicating satisfaction with comfort), the participant will use 13 mm 
devices for the remaining 2 weeks of their fitting period and complete daily bowel diaries.   
2) At the end of this fitting period, the subject comfort will be reassessed with question #7 of the 
QUEST questionnaire.  Subjects who report QUEST scores of 1-2 (indicating dissatisfaction with 
comfort) with the 13mm device will use the 10mm device for the entire treatment period.  
However, subjects who report QUEST scores of 3-5 (indicating satisfaction with comfort) at the 
end of the fitting period will proceed immediately to the treatment period and will continue 
using the size 13mm device for the entire treatment period. 
3) Subjects who begin with the 13mm device will use the device for a minimum of two weeks 
during the fitting period.  Thereafter, the subject will proceed to the treatment period and will 
continue using the 13mm device for the entire treatment period.  
 
Subjects will be contacted at least twice per month during the fitting period.  Attempts will be made to 
space these calls at an interval of 7 days. 
 
This sequence is shown in the following flow diagram: 

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1 The screening visit may occur within 21 days before the first day of the baseline period; bowel diary.  
During the baseline period, subjects will maintain bowel diaries for 28 consecutive days.   
2 Depending on the logistics of scheduling, this visit will generally last 1-2 days.  It can take place at any 
time between days 28-38.   
3 The treatment period will begin within 7 days after the assessment 
 is complete.       
4 Vital signs (VS) are to be obtained in the sitting position after at least 5 minutes of rest.  Body 
temperature (°C) and respiration rate (breaths/minute) will also be recorded.  Height (cm) and weight 
(kg) will be recorded in light clothing without shoes.   
5 
intake will be assessed at baseline using
 
. 
 
* After the treatment period, all individuals who withdraw for reasons other than personal preference 
(i.e., for medical reasons) and a minimum of 50% of all patients shall undergo an evaluation by anoscopy 
following the treatment period to assess for device related trauma.  
 
List of Patient Facing Documents (submitted under separate cover): 
 
• 
 
• 
Quebec User Evaluation of Satisfaction with Assistive Technology 
• 
Weekly Global Fecal Incontinence Questionnaire 
• 
Bowel Habits Diary 
• 
Emotional Distress - Anxiety Short Form 8a 
• 
Severity of Fecal Incontinence - Baseline 
• 
Severity of Fecal Incontinence - Post-Treatment 
• 
Criteria for Fecal Incontinence 
• 
Therapy Evaluation Form 
• 
Impact of Fecal Incontinence and Quality of Life (FIQOL Scale) 
• 
Ease of Use, Usability, and Comfort Scale 
• 
Instructions for Use 
• 
Product Ordering Instructions 
 
 
 
2 
 
INTRODUCTION 
 
2.1 
STUDY RATIONALE  
Because existing approaches to manage FI are of limited efficacy,4 there is an unmet need for additional 
approaches to manage this symptom, which can have a potentially devastating impact on quality of life.  
A systematic review observed that while anal plugs might be helpful in some subjects, they are poorly 
tolerated, with a dropout rate ranging from 12.5% to 68% across the four studies32.   Another device, the 
Renew anal insert device (Renew Medical Inc., Foster City, CA), is approved for treating FI in the United 
States.  In the intent-to-treat analysis, 62% of subjects achieved ≥ 50% reduction in the frequency of FI 

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with that device.7  The Minnesota Medical Technologies Anal Insert Device is designed to engage with 
and conform to the anorectal junction and the anal canal to provide an anatomical fit in order to protect 
against bypass leakage.  The device is very soft and pliable which is expected to provide superior 
performance relative to devices which are currently on the market, with relatively few adverse events 
and good patient acceptance. 
2.2 
BACKGROUND  
Fecal incontinence (FI) is a common symptom that can significantly impair quality of life.1  FI, the 
involuntary leakage of stool from the anus, is a common symptom not only in nursing home residents, 
but also in the community.  Almost one of 15 adult women have moderate to severe FI.2   
Therapeutic options for FI include dietary modification and education, medications to manage bowel 
disturbances, pelvic floor retraining by biofeedback therapy, anal plugs, minimally invasive procedures 
(i.e., perianal injection of a bulking agent and sacral nerve stimulation), and surgery (e.g., anal 
sphincteroplasty).3  The approaches are of limited efficacy.4  The use of medications is often limited by 
constipation.     
At present, FI is attributed to bowel disturbances, particularly diarrhea, anorectal dysfunctions, and 
pelvic floor injury.1  Pelvic floor injury, which may result from obstetric injury, iatrogenic factors, is often 
irreversible and may manifest as a patulous anal canal.5  Anal plugs have been used to restore the anal 
seal.  A Cochrane review identified 4 randomized cross-over or parallel studies of anal plugs, none of 
which are available in the United States.6  This review observed that while anal plugs might be helpful in 
some patients but are poorly tolerated, with a dropout rate ranging from 12.5% to 68% across the four 
studies.  More recently, based on open label studies, an anal and a vaginal device have been FDA-
approved for treating FI in the United States.  For the Renew anal insert device (Renew Medical Inc., 
Foster City, CA), the intent-to-treat analysis observed that 62% of patients achieved ≥  50% reduction in 
the frequency of FI.7  78% of users were extremely satisfied with the device.  There were no serious 
adverse events and only 3 moderate adverse events (i.e., fecal urgency, soreness, and bleeding 
hemorrhoids).   
Another device incorporates a vaginal insert and pressure-regulated pump.8  In the pivotal trial, 61 of 
110 subjects completed successful fitting of the device.  Of these, 78.7% achieved treatment success, 
defined as >50% reduction of incontinent episodes at 1 month. 
Because many women with FI
 
to FI.  For example, while several small studies observed 
 
 we recently observed 
 
 There are no 
data on the 
 associated 
with FI.  Hence we propose to explore these questions in this study. 

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2.3 
RISK/BENEFIT ASSESSMENT   
 
2.3.1 KNOWN POTENTIAL RISKS  
Only subjects who satisfy stringent inclusion and exclusion criteria and provide written informed 
consent will be included in the protocol.  Additional details as follows: 
The Minnesota Medical Technologies Anal Insert Device is manufactured of biocompatible materials 
which are soft and pliable.  The user interface has been designed such that use errors are either 
eliminated or reduced to the extent possible. 
All study procedures are standard of care, with the exception of the study-specific physical 
examination and 
 
 assessment, additional questionnaires, 
 
with study device inserted, subject self-insertion and evacuation of the MMT Anal Insert Device. 
Anticipated risks for this study include: 
• 
Mild discomfort 
• 
Unexpected expulsion of the device 
• 
New onset, or, if pre-existing, increased anorectal pain or discomfort 
• 
Diarrhea 
• 
Abdominal pain 
• 
Anorectal irritation, pain, soreness 
• 
Rectal, anal, or perianal infection 
• 
Device over-insertion or device migration into anal canal or rectum 
• 
Injury to anus, anal canal, or rectum 
• 
New onset, or, if pre-existing, increased anorectal urge 
• 
New onset, or, if pre-existing, increased abdominal gas 
• 
New onset, or, if pre-existing, increased hemorrhoids or rectal bleeding 
• 
New onset, or, if pre-existing, increased colonic obstruction or fecal impaction 
• 
Perforation of anal canal or rectum 
• 
Device breakage 
• 
Discomfort, bruising, redness, swelling, bleeding around the site of the blood draw 
• 
Feeling of lightheadedness when blood is drawn 
• 
Infection at the site of the blood draw 
• 
Rectal bleeding due to rectal catheter use 
• 
Allergic reaction to materials of the testing equipment or study device 

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• 
If a researcher finds that results obtained from the 
 performed on patient 
, the subject will be contacted and 
 
. 
There may be additional risks to subjects or embryos or fetuses in women who are of childbearing 
potential that are not known at this time.  Any new significant information learned during this study that 
could impact a subject’s decision to participate in the study will be communicated to the subject. 
 
2.3.2 KNOWN POTENTIAL BENEFITS  
There are no known benefits to the use of this device.  Data gathered in this study may be of use in 
future treatment of subjects with fecal incontinence. 
2.3.3 ASSESSMENT OF POTENTIAL RISKS AND BENEFITS  
The Minnesota Medical Technologies Anal Insert Device is a device which has similar technical and 
biological characteristics with other anal inserts currently available for the treatment of FI.  
Conservative treatments for FI include lifestyle changes, dietary modifications, bowel management 
programs (medications and enemas), and pelvic floor muscle exercises, physical therapy with or without 
biofeedback therapy.30 These treatments have minimal risk.    
Surgical approaches to treat FI are high risk solutions.  
Anal inserts provide a conservative middle step in treatment options between alternative treatments 
such as lifestyle changes, medications, pelvic exercises, physical therapy. and surgical treatments. 
3 
OBJECTIVES AND ENDPOINTS 
 
1.  Primary:  Primary Effectiveness Endpoint: A Relative Percentage Change in Episodes of Accidental 
Bowel Leakage (ABL) Determined by Comparing Treatment Results to Pre-treatment 
Results From the Baseline Period as Measured by Daily Diary Recordings .   [Time Frame: 
Reduction in accidental bowel leakage from 4 week baseline period through 4 week 
treatment period (approximately Weeks 9-12). 
 
Measure Type 
Primary 
Measure Title 
Primary Effectiveness Endpoint: A Relative Percentage Change in Episodes of 
Accidental Bowel Leakage (ABL) Determined by Comparing Treatment Results to 
Pre-treatment Results From the Baseline Period as Measured by Daily Diary 
Recordings. 
Measure Description 
This primary effectiveness endpoint will be calculated as a relative percentage 

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of the baseline Accidental Bowel Leakage (ABL) using the following equation: % 
reduction in ABL = 100*(baseline period ABL - treatment period ABL) / (baseline 
period ABL) 
Time Frame 
Reduction in accidental bowel leakage from 4 week baseline period through 4 
week treatment period (approximately Weeks 9-12).   
 
 
Secondary Efficacy Endpoint(s):  
- 
The mean % reduction in Fecal Incontinence Severity Index (FISS) score from the baseline period 
to the end of the treatment period, calculated according to the following equation:  % reduction 
in FISS  = 100% (baseline period FISS - end treatment period FISS) /  (baseline period FISS). 
- 
The proportion of subjects in whom the frequency of FI episodes during the treatment period is 
greater than or equal to 75% lower than the frequency observed during baseline period.   
- 
The proportion of subjects in whom, during treatment period, the device will reduce the 
number of days with FI by 50% as compared to baseline. 
- 
The proportion of subjects in whom the device will reduce the volume of FI during treatment 
period as compared to baseline. 
- 
The proportion of subjects in whom the Minnesota Medical Technologies Anal Insert Device 
reduces the proportion of FI episodes which are associated with diarrhea. 
- 
The proportion of subjects in whom the Minnesota Medical Technologies Anal Insert Device 
reduces the number of episodes of passive and of urge FI 
- 
The proportion of subjects in whom the Minnesota Medical Technologies Anal Insert Device 
improves the Quality of Life (QOL) related to FI during treatment as compared to baseline. 
- 
The proportion of subjects in whom the Minnesota Medical Technologies Anal Insert Device will 
affect the composition of stool leakage during treatment as compared to baseline. 
- 
The proportion of subjects are satisfied with the Minnesota Medical Technologies Anal Insert 
Device. 
- 
The time for which a bowel movement can be deferred after the occurrence of urgency will be 
affected by the Minnesota Medical Technologies Anal Insert Device. 
- 
The proportion of complete bowel movements will be affected by the Minnesota Medical 
Technologies Anal Insert Device during treatment as compared to baseline. 
- 
Treatment with the Minnesota Medical Technologies Anal Insert Device will affect anxiety and 
depression during treatment as compared to baseline. 
- 
The Minnesota Medical Technologies Anal Insert Device reduces the use of medications for FI 
during treatment as compared to baseline. 
- 
Exploratory Endpoints: 
- 
-  Evaluate in up to 
 subjects the effects of the Minnesota Medical Technologies 
Anal Insert Device 
, as measured 
 
. 

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OBJECTIVES 
ENDPOINTS 
JUSTIFICATION FOR 
ENDPOINTS 
whom the device will reduce the 
volume of FI during treatment period 
as compared to baseline. 
•  The proportion of subjects in 
whom the Minnesota Medical 
Technologies Anal Insert Device 
reduces the proportion of FI episodes 
which are associated with diarrhea. 
•  The proportion of subjects in 
whom the Minnesota Medical 
Technologies Anal Insert Device 
reduces the number of episodes of 
passive and of urge FI 
•  The proportion of subjects in 
whom the Minnesota Medical 
Technologies Anal Insert Device will 
improve the Quality of Life (QOL) 
related to FI during treatment period 
as compared to baseline. 
•  The proportion of subjects in 
whom the Minnesota Medical 
Technologies Anal Insert Device will 
affect the composition of stool 
leakage during treatment period as 
compared to baseline. 
•  The proportion of subjects are 
satisfied with the Minnesota Medical 
Technologies Anal Insert Device. 
•  The time for which a bowel 
movement can be deferred after the 
occurrence of urgency will be 
affected by the Minnesota Medical 
Technologies Anal Insert Device. 
•  The proportion of complete bowel 
movements will be affected by the 
Minnesota Medical Technologies 
Anal Insert Device during treatment 
period as compared to baseline. 
•  Treatment with the Minnesota 
Medical Technologies Anal Insert 
Device will affect anxiety and 
depression during treatment period 
as compared to baseline. 

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During this visit to the Mayo Clinic study site, subjects will receive the following assessments: baseline 
anoscopy (if not already performed within 6 months of informed consent), assessment of 
 
, a 
, and 
.  In 
up to 
subjects who agree to participate in the 
sub-study, 
 will be assessed 
. 
 
Subjects who participate in the 2 to 4 week fitting period will insert the device after each bowel 
evacuation or expelling of the device, inserting only one device at a time and inserting a new device 
after each bowel evacuation or device expulsion.   Subjects will be evaluated to determine which of two 
device sizes (10mm or 13mm) is preferred.  Any changes in the use of device size will occur during the 
fitting period to ensure that the same size device is worn during the entire treatment period.   
 
Subjects will proceed to a 4-week treatment period in which information on fecal incontinence, bowel 
habits, and global measures will be collected.  Subjects will be asked to complete daily bowel diaries for 
4 weeks during the Treatment period and to complete weekly questionnaires.  After use, devices and 
applicators will be disposed of by subjects and not returned to the clinic, unless the subjects report 
concerns about the device function, in which case, subjects will be asked to return the expelled device 
to the clinic or directly to the sponsor, for device analysis.     
While completing the treatment period of 4 weeks of daily diaries and weekly questionnaires, subjects 
will be asked to mail these diaries and questionnaires to the site on a weekly basis.  At the end of the 
treatment period, subjects will be asked to complete additional fecal incontinence, quality of life and 
satisfaction questionnaires and mail them to the study site.   Adverse events will be assessed between 
enrollment and study exit.  Subjects will be asked to dispose of all unused devices and to confirm this 
with the study site. 
After the treatment period, all individuals who withdraw for reasons other than personal preference 
(i.e., for medical reasons) and a minimum of 50% of all patients shall undergo an evaluation by anoscopy 
following the treatment period to assess for device related trauma.  
4.2 
SCIENTIFIC RATIONALE FOR STUDY DESIGN 
Because existing approaches to manage FI are of limited efficacy,4 there is an unmet need for additional 
approaches to manage this symptom, which can have a potentially devastating impact on QOL.  A 
systematic review observed that while anal plugs might be helpful in some patients, they are poorly 
tolerated, with a dropout rate ranging from 12.5% to 68% across the four studies32.  Another device, the 
Renew anal insert device (Renew Medical Inc., Foster City, CA), is approved for treating FI in the United 
States.  In the intent-to-treat analysis, 62% of patients achieved ≥  50% reduction in the frequency of FI 
with that device.7  The Minnesota Medical Technologies Anal Insert Device is designed to engage with 
and conform to the anorectal junction and the anal canal to provide an anatomical fit in order to protect 
against bypass leakage.  The device is very soft and pliable which is expected to provide superior 
performance relative to devices which are currently on the market, with relatively few adverse events 
and good patient acceptance. 
4.3 
JUSTIFICATION FOR TREATMENT 

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The treatment of anal leakage and bowel incontinence includes a range of treatments from lifestyle 
changes to surgical options.  This study is designed to evaluate a low-risk, minimally invasive self-
insertion anal device to help block anal leakage and bowel incontinence by assisting the body in forming 
a seal to reduce or block leakage.   
The Minnesota Medical Technologies Anal Insert Device size was selected for design based on studies 
that characterized the anal canal in subjects with anorectal disorders.  Among a cohort 119 patients with 
anorectal disorders, 49 patients (41%) had a patulous anal canal, which was more common in patients 
with FI (58%) than constipation (25%).5  A patulous canal is associated with, and likely consequent to 
injury to the anal sphincters and pelvic floor muscles.  It predisposes to fecal leakage.  In that study, the 
anal canal diameter was ≤ 10 mm in 39 of 49 patients with a patulous canal; in the remainder, the 
diameter was between 10 and 20 mm.  Hence, the Minnesota Medical Technologies Anal Insert Device 
will be available in two sizes (i.e., 10mm and 13mm).   
4.4 
END OF STUDY DEFINITION 
Subject participation is voluntary, and subjects may leave the study at any time.  Subjects will be 
instructed to contact their doctor if they choose to leave the study, to make arrangements for standard 
of care treatment of their fecal incontinence moving forward and to assess if the subjects experienced 
any adverse events.  The study sponsor or the U.S. Food and Drug Administration may decide to stop the 
study at any time.  The study investigators may decide that participation in the study is not in the 
subject’s best interest for health reasons.  
 
A subject is considered to have withdrawn or been withdrawn from the study, or if the subject has 
completed all phases of the study including the last visit or the last scheduled procedure shown in the 
Schedule of Activities (SoA), Section 1.3.  The end of the study is defined as completion of the last 
subject’s last visit or procedure shown in the SoA in the trial globally.   
 
5 
STUDY POPULATION 
A sufficient number (up to 150) of subjects with a diagnosis of fecal incontinence in the general 
population of Mayo Clinic will be screened and consented for eligibility to participate in the study and to 
facilitate the enrollment of 60 subjects into the treatment period of the study.  Of these, up to 
 
 of the subjects will be recruited for the 
sub-study.  
The specific inclusion and exclusion criteria for enrolling subjects in this study are presented below.  
Exceptions to these inclusion and exclusion criteria must be discussed in advance and approved by the 
Principal investigator and sponsor.  Any exemptions to the study entry criteria will be documented in the 
source documents and on the appropriate page of the case report form. 
5.1 
INCLUSION CRITERIA 
Male and female subjects aged 18 years and older at screening who meet the following inclusion criteria 
and none of the exclusion criteria will be eligible for enrollment: 
- 
Able to provide signed (written) informed consent    

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- 
Diagnosis of fecal incontinence, with duration of symptoms six months or longer with a history 
of at least one fecal incontinence (FI) episode per week or at least four episodes per month 
- 
Subject comprehends study meaning and is capable of carrying out study duties 
- 
Patient is fluent in English as study questionnaires have been validated using English    
- 
 If female and of childbearing potential, patient has had a negative urine pregnancy test within 21 days of 
the first day of the baseline visit 
 - 
If applicable, Patient agrees to use acceptable birth control (surgical sterilization, abstinence, 
approved hormonal contraceptives such as birth control pills, barrier methods such as condom 
or diaphragm used with a spermicide, or an intrauterine device (IUD)).  If not applicable, the 
reason why shall be documented on the screening log.   
- 
Subject is at least 18 years of age at time of consent 
- 
Patients has failed conservative medical therapy (i.e., the use of bulking agents, anti-diarrheal 
agents (e.g., loperamide) and biofeedback therapy as appropriate) for Fecal Incontinence 
 
 
5.2 
EXCLUSION CRITERIA 
Subjects who meet the following criteria will be excluded from enrollment: 
- 
Unable or unwilling to provide informed consent or to comply with study procedures 
- 
History of anorectal pathology in the past 6 months (perianal abscess or fistula, fecal impaction, 
or clinically significant rectocele). 
- 
History of inflammatory bowel disease with active proctosigmoiditis  
- 
History of rectal surgery in past 6 months where the Investigator determines that the use of the 
study device may be associated with an increased risk of complications. 
- 
History of acute or chronic illness or history of illness or any other reason which in the opinion of 
the Investigator, could pose a threat or harm to the subject or obscure interpretation of 
laboratory test results or interpretation of study data such as frequent angina, Class III or IV 
congestive heart failure, etc. The reason for exclusion of any enrolled subject shall be 
documented on the screening log.     
- 
Patient has known clinically-significant immune deficiency state (e.g., HIV infection).  
- 
Patient is taking drugs with a low therapeutic index, such as warfarin, digoxin, and anti-seizure 
medications 
- 
If patient has clinically suspected upper or lower gastrointestinal (GI) obstruction, they must be 
excluded or have been evaluated per standard of care and obstruction ruled out before 
screening.  Determination of obstruction shall be documented on the screening log. 
- 
History of fecal impaction with overflow diarrhea in the past 6 months 
- 
History of Ileo-anal pouch 
- 
History of allergy to silicone or one of its components 
- 
Patient is pregnant and/or nursing 
- 
Any other reason, which in the opinion of the Investigator, would confound proper 
interpretation of the study 
- 
Patient whom, after training from a healthcare provider, cannot insert or expel the device 
themself or with assistance from a caregiver 
- 
History of anal or rectal pain and/or rectal bleeding in the past month 
- 
Subject cannot retain either device (10 or 13 mm) while ambulating at the screening visit 

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- 
Post baseline anoscopy examination, presence of an anal fissure, Grade III-IV internal 
hemorrhoids, or thrombosed external hemorrhoids. 
 
 
In addition, subjects will not be eligible to participate in the Treatment Period if during the baseline 
period or at the 
 visit:   
- 
Used rescue medications beyond those allowed by the protocol  
- 
demonstrated lack of compliance (for e.g., did not complete bowel diaries for 3 days in any 
week during the baseline diary period) 
Subjects will not be considered for the optional 
sub-study if: 
- 
they are not eligible to proceed to the treatment period  
- 
they have contraindications for 
 e.g., subjects have 
 
, such as, c
 
 
- 
American Society of Anesthesiologist (ASA) score of 4 or higher  
 
5.3 
LIFESTYLE CONSIDERATIONS 
Not-applicable. 
 
5.4 
SCREEN FAILURES 
Subjects who are candidates for enrollment into the study will be evaluated for eligibility by the 
Investigator to ensure that the inclusion and exclusion criteria have been satisfied and that the subject is 
eligible for participation in this clinical study.  Subjects who consent to participate in the study but (i) 
withdraw before participating in the baseline bowel diary because they can retain neither device size at 
the screening visit or no longer satisfy eligibility criteria (e.g., because they developed an inter-current 
illness) or (ii) do not have 4 or more episodes of FI during the 4-week baseline diary period will be 
considered screen failures.   
Subjects will be informed that they have the right to withdraw from the study at any time for any 
reason, without prejudice to their medical care, penalty, or loss of benefits.  The Investigator also has 
the right to withdraw subjects from the study for any of the following reasons: 
- 
Adverse events which, in the judgment of the Investigator, justify treatment study 
withdrawal 
- 
Non-adherence to study device use regimen or protocol requirements 
- 
Non-compliance with instructions 
- 
General or specific changes in the subject’s condition unacceptable for further treatment in 
the judgment of the Investigator 
- 
Subject requires use of an unacceptable concomitant medication 
- 
Subject no longer meets the study inclusion or meets exclusion criteria  
- 
Subject request 

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- 
Sponsor or FDA terminates study 
- 
Administrative reasons  
If a subject is withdrawn or discontinued from the study, the primary reason for withdrawal from the 
study is to be recorded in the source documents. If the subjects withdraws or is withdrawn prior to 
consent, the reason should be documented on the screening log.  If the subject withdraws or is 
withdrawn after consent, the reason should be documented on the Case Report Forms (CRFs).   All 
subjects withdrawn prior to completing the study should be encouraged to complete study safety 
assessments.  All adverse events should be followed to resolution as described in Section 7. 
Subjects who withdraw from the study prior to completion of 
 will be included in 
study intent to treat analysis and additional subjects will be enrolled into the 
sub-study to achieve 
the goal of 
 subjects completing all study activities per protocol.  In the event that an enrolled subject 
does not wish to participate in the 
sub-study and this subject continues to meet all study 
inclusion/exclusion criteria, that subject may proceed to the Fitting and Treatment phases of this study.  
5.5 
STRATEGIES FOR RECRUITMENT AND RETENTION 
All men and women aged 18 years and older will be eligible to participate regardless of ethnicity.  The 
study may enroll up to 150 subjects until 60 subjects have been treated with the study device.  Up to 
 subjects will be enrolled in the 
sub-study.  It is anticipated that that subjects will be 
recruited over 10-12 months from the outpatient clinic and patient databases at Mayo Clinic, Rochester 
and by public advertisement.  Potential subjects may be approached by advertising, letter, phone, in 
person, or by e mail.  All patient-facing materials will have sponsor and IRB approval prior to use.  It is 
anticipated that the distribution of sex, race, and ethnicity will be consistent with the 2016 American 
Community Survey (ie, White (86.1%), African American (6.4%), Asian (7.1%), American Indian (0.8%), 
and other (1.6%).    
 
6 
STUDY INTERVENTION 
 
6.1 
STUDY INTERVENTION(S) ADMINISTRATION 
 
6.1.1 STUDY INTERVENTION DESCRIPTION 
 
This Minnesota Medical Technologies Anal Insert Device is a non-sterile 
soft, flexible, liquid-filled anal insert meant for single use only (Figure 3).  
The device is self-inserted into the anal canal where the liquid-filled bulb 
of the device is designed to rest against, conform to, and provide a seal 
at the anorectal junction to prevent fecal discharge from the rectum. The 
liquid-filled shaft of the device is designed to conform to and fill the anal 
canal allowing the pressure from the internal and external anal 
sphincters to seal the canal. The device’s external retainer flare is 
designed to rest against the outside of the anus and prevent migration of 
Figure 3: Minnesota 
Medical Technologies 
Anal Insert Device.  

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the insert into the anal canal and rectum. These mechanisms are designed to work together to prevent 
the involuntary leakage of fecal matter through the anal canal. 
Subjects will be instructed to grasp the applicator and device retainer in their hand (Figure 3).  After 
relaxing their anorectal muscles, subjects will gently insert the device until the retainer rests on the 
anus.  The applicator is to be withdrawn and discarded.  The bulbous tip is designed to facilitate 
retention of the device in the rectum.    
 
  
6.1.2 DEVICE ADMINISTRATION 
   
The sizes to be evaluated in this study are: 
- 
Minnesota Medical Technologies Anal Insert Device 10 mm size – to be inserted in the anorectum 
during the day. Subjects who have nocturnal FI should also use the device at night. 
- 
Minnesota Medical Technologies Anal Insert Device 13 mm size – to be inserted in the anorectum 
during the day. Subjects who have nocturnal FI should also use the device at night.  
At the screening visit, the 10 mm, and, if necessary thereafter, the 13 mm device will be inserted into 
the rectum to determine if the device stays in situ while subjects are ambulating.  Subjects who can 
retain neither device size will be withdrawn from the study.  
 
Study subjects eligible for the study at the end of the baseline period will be given instructions as to 
ordering the study devices to be shipped to them by Minnesota Medical Technologies.    The clinical site 
will train study subjects in the proper use of devices. 
 
Eligible study subjects will proceed to a up to  4-week fitting period where subjects will evaluate which 
of two device sizes (10mm or 13mm) is preferred.  Subjects who can retain the 10mm device at the 
screening visit will begin the fitting period with the 10mm device.  Subjects who cannot retain the 10 
mm but can retain the 13 mm device will begin the fitting period with the 13 mm device.  The sequence 
of events for the fitting period will be as follows: 
1) Subjects who begin with the 10 mm device will use the device for a minimum of 2 weeks during 
the fitting period.  , Subjects will be asked to complete daily bowel diaries  to determine the 
percent reduction in FI episodes, and subject comfort will be assessed using question #7 on the 
QUEST questionnaire.  If greater than or equal to 75% reduction in FI episodes is observed 
during this fitting period, the subject will proceed immediately to the treatment period and will 
continue using the 10mm device for the entire treatment period.      If the reduction in FI 
episodes is less than 75%, and the QUEST score is 1-2 (indicating dissatisfaction with comfort), 
the subject will proceed immediately to the treatment period and will continue using the 10mm 
device for the entire treatment period.   If the reduction in FI episodes is less than 75%, and the 
QUEST score is 3-5 (indicating satisfaction with comfort), the participant will use 13 mm devices 

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for a minimum of 2 weeks as their fitting period and complete daily bowel diaries.  At the end of 
this fitting period, the subject comfort will be reassessed with question #7 of the QUEST 
questionnaire.  Subjects who report QUEST scores of 1-2 (indicating dissatisfaction with 
comfort) with the 13mm device will use the 10mm device for the entire treatment period.  
However, subjects who report QUEST scores of 3-5 (indicating satisfaction with comfort) at the 
end of the fitting period will proceed immediately to the treatment period and will continue 
using the size 13mm device for the entire treatment period. 
2) Subjects who begin with the 13mm device will use the device for a minimum of two weeks 
during the fitting period.  Thereafter, the subject will proceed to the treatment period and will 
continue using the 13mm device for the entire treatment period.  
 
Subjects will be contacted at least twice per month during the fitting period.  Attempts will be made to 
space these calls at an interval of 7 days.  The devices which they are assigned to receive will be 
dispensed to study subjects by Minnesota Medical Technologies for use during the treatment period.   
The devices will be packaged individually.  Each subject will self-administer the devices.  Subjects will be 
provided instructions for how to order the device and also an Instructions For Use, both of which will 
have Institutional Review Board (IRB) approval prior to use. 
After the treatment period, all individuals who withdraw for reasons other than personal preference 
(i.e., for medical reasons) and a minimum of 50% of all patients shall undergo an evaluation by anoscopy 
following the treatment period to assess for device related trauma 
6.2 
PREPARATION/HANDLING/STORAGE/ACCOUNTABILITY 
 
6.2.1 ACQUISITION AND ACCOUNTABILITY 
 will ship study devices to the study site using a trackable courier for 
use in the 
.  Accountability for the study devices at the study site is the responsibility of 
the Investigator and their designated staff as well as the subjects.  The study site personnel will instruct 
subjects to use study devices are used only in accordance with this protocol. The Investigator may 
choose to assign Mayo clinic device accountability responsibilities to an appropriate Mayo study team 
member.  Accountability records will include dates, quantities, batch/serial numbers, expiration dates (if 
applicable), and subject numbers.  The Sponsor or its designee will review devices accountability at the 
site on an ongoing basis during monitoring visits and at the end of the study when all unused devices are 
returned or disposed of, per sponsor instructions. 
Device accountability records will be maintained by Minnesota Medical Technologies to document the 
batch/serial number, quantity, size, and date shipped to or from subjects.  Devices will be provided to 
subjects using a trackable courier.  Subjects will be responsible for keeping their study devices secure 
and for confirming with the study site that they (the subjects) have disposed of all unused and used 

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devices.  The exception to this process will be if a subject experiences a device deficiency or 
malfunction.  In this case, the subject will be asked to return the device to the study site or to Minnesota 
Medical Technologies for analysis, using trackable courier as the shipping method. 
     
  
6.2.2 FORMULATION, APPEARANCE, PACKAGING, AND LABELING 
Study subjects eligible for the study at the end of the baseline period will be dispensed the devices.  
Clinical sites will train study subjects (or a caregiver) in the proper use of devices.   
The sizes to be evaluated in this study are: 
- 
Minnesota Medical Technologies Anal Insert Device 10 mm size. 
- 
Minnesota Medical Technologies Anal Insert Device 13 mm size.  
o The devices will be packaged individually for patient use.  Each subject will self-
administer the devices 
Study devices are packaged in kits for subjects enrolled in the study.   
Study packages will contain the following information: 
- 
Caution:  Investigational device - Limited by United States Law to Investigational Use. 
Study packages will not bear any statement that is false or misleading in any manner or represents that 
the study device is safe or effective for the purposes for which it is being investigated. 
A copy of package labeling is provided under separate cover.   Any changes to package labeling during 
the study, if applicable, will be provided under separate cover to the IRB and study site. 
6.2.3 PRODUCT STORAGE AND STABILITY 
All study devices are for investigational use only and are to be used only within the context of this study. 
All study devices will be supplied by Minnesota Medical Technologies. 
The device is provided non-sterile in individual single-use packages which are shelf-stable at ambient 
temperature.  Device size is indirectly indicated on the package label with a device code 
 
.  Multiple individually packaged devices and a single IFU sheet are placed in a box for 
distribution to subjects.   Study site must store devices in a secure location accessible only to authorized 
personnel. 
 
6.2.4 PREPARATION 
 

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No special preparation is required for this device.  The device will be removed from the package and 
inserted by the subject according to the instructions for use. 
 
6.3 
MEASURES TO MINIMIZE BIAS: RANDOMIZATION AND BLINDING 
This is a within-subject control study with a 4-week baseline period followed by a 2 to 4-week fitting 
period and a 4-week treatment period.    Up to 
 subjects who meet all inclusion and meet 
no exclusion criteria at the end of the baseline phase of the study may be included in the optional 
 
sub-study 
Subjects who are candidates for screening into the study will be evaluated for eligibility by the 
Investigator to ensure that the inclusion and exclusion criteria have been satisfied.  Once the subject 
signs the informed consent, they are considered enrolled in the study.  At that time, the study site 
personnel will register the subject and assign a sequential and unique subject number.  Once a subject 
number has been assigned, it cannot be reused.   
 
 
6.4 
STUDY INTERVENTION COMPLIANCE 
In order to evaluate the efficacy, safety and tolerability of the study device, it is critical that subjects use 
the study device as directed.  All unused devices will be disposed of.  Only one device is to be used at a 
time.  All study devices are to be self-administered by the study subject or a trained caregiver.  Subjects 
will be required to answer a question using the daily stool diary regarding administration of their study 
devices each day during the treatment period. 
If a subject does not receive or use all assigned study devices, the reason is to be recorded in source 
documents and the CRF. 
Subject will be contacted via telephone by the study site personnel during the study to encourage the 
subject to be compliant in completion of daily bowel diaries and questionnaires and to ensure reporting 
of adverse events. 
 
6.5 
CONCOMITANT THERAPY 
Concomitant procedures: conducted during the study, including those used to treat adverse events, are 
to be reported in the source documents and on the CRF.  Exceptions to inclusion and exclusion criteria 
must be discussed in advance and approved by the Principal investigator and sponsor.  Any exemptions 
to the study entry criteria will be documented in the source documents and on the appropriate pages of 
the case report form, including protocol deviations. 
Permitted Medication:  Subjects must be on a stable dose of any chronic concomitant medications 
while participating in the study.  This is defined as no changes in regimen for at least 2 weeks prior to 

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Day 1.  [Daily adjustments of insulin doses or other medications used for non-gastrointestinal  diseases 
(e.g., diuretics) are permitted.]  
 
If it becomes necessary for a subject to take any other medication during the study, the specific 
medication(s) and indication(s) must be discussed with the Investigator prior to beginning this 
medication.  All concomitant medications taken during the course of the study must be recorded in the 
source documents and the CRF. 
Prohibited Medication and Substances:  Medications that could impact the efficacy assessments during 
the study are prohibited.  Subjects must withdraw from opioids at least 48 hours prior to the baseline 
period and throughout the study participation (except as protocol defined rescue medications).  Other 
medications that alter gastrointestinal GI transit including 
 
 will be permitted as 
long as these medications are prescribed for regular (i.e., not as needed) use and the dose is stable for 2 
weeks before the study.  Drugs with a low therapeutic index, such as 
 
medications are prohibited.  All medications shall be reviewed and dis/approved by the investigator or 
sub-investigator on a case by case basis).  Medications that may impact fecal incontinence will be 
tracked on a concomitant medication log. 
6.5.1 RESCUE MEDICINE 
Use of drugs after Day 1 which may impact efficacy evaluations is strongly discouraged.  Subjects who 
need rescue medication, i.e., if they have 3 watery bowel movements in 24 hours, can use loperamide as 
needed at a dose of 2 mg every 6 hours, with no more than four doses over the course of 24 hours and 
no more than seven doses over the course of 48 hours.  Subjects who need rescue medication for 
constipation, after three full days without a bowel movement, can receive 1-2 bisacodyl 5 mg tabs or a 
bisacodyl suppository (10 mg).  In addition, subjects who need relief of mild pain can use analgesic drugs 
such as NSAIDs and COX-2 inhibitors for up to two doses per week.  Intake of acetaminophen up to 1.5g 
per day in divided doses is permissible.  Subjects who need rescue medication for constipation, after 
three full days without a bowel movement, can receive 1-2 bisacodyl 5 mg tabs or a bisacodyl 
suppository (10 mg).    
 
6.6 
DISCONTINUATION OF STUDY INTERVENTION 
This study may be prematurely terminated if, in the opinion of the Investigator or Minnesota Medical 
Technologies or the Institutional Review Board, there is sufficient reasonable cause.  Written notification 
documenting the reason for study termination will be provided to the Investigator or Minnesota Medical 
Technologies by the terminating party and all required regulatory notifications will be made.  
Circumstances that may warrant termination include, but are not limited to: 
- 
Determination of unexpected, significant, or unacceptable risk to subjects. 

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- 
Insufficient complete and/or evaluable data. 
- 
Plans to modify, suspend or discontinue the development of the study device. 
Should the study be closed prematurely, all study materials must be returned to Minnesota Medical 
Technologies or designee. 
 
6.7 
PARTICIPANT DISCONTINUATION/WITHDRAWAL FROM THE STUDY 
If signs of a major side effect (e.g., rectal perforation) should occur, the subject will be treated as 
clinically indicated and Principal Investigator and Sponsor will be notified immediately.  Such events will 
be reported on the case report form.   
Patients with AEs will be evaluated by the investigator. An anoscopy will be performed to determine the 
etiology of anal pain or bleeding and if a significant anal-rectal abnormality is identified the patient will 
exit the study. Any data collected from a patient who is withdrawn because of an AE will be included in 
the ITT safety but not effectiveness summary. Any patient with a mucosal abnormality should be 
followed to resolution.  After the treatment period, all individuals who withdraw for reasons other than 
personal preference (i.e., for medical reasons) and a minimum of 50% of all patients shall undergo an 
evaluation by anoscopy following the treatment period to assess for device related trauma. 
Subjects will be informed that they have the right to withdraw from the study at any time for any 
reason, without prejudice to their medical care, penalty or loss of benefits.  If the subject withdraws, 
they should be treated with standard of care.  The Investigator also has the right to withdraw subjects 
from the study for any of the following reasons: 
- 
Adverse events which, in the judgment of the Investigator, justify treatment study 
withdrawal 
- 
Non-adherence to study device use regimen or protocol requirements 
- 
Non-compliance with instructions 
- 
General or specific changes in the subject’s condition unacceptable for further treatment in 
the judgment of the Investigator 
- 
Subject requires use of an unacceptable concomitant medication 
- 
Subject no longer meets the protocol criteria (Section 4.2) 
- 
Subject request 
- 
Administrative reasons 
If a subject is withdrawn or discontinued from the study, the primary reason for withdrawal from the 
study is to be recorded in the source documents and the Case Report Form.  All subjects withdrawn 
prior to completing the study should be encouraged to complete study safety assessments.   
6.8 
LOST TO FOLLOW-UP 

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A subject will be considered lost to follow-up if he or she is unable to be contacted by the study site 
staff.  
 
The following actions must be taken if a subject fails to return to the clinic for a required study visit: 
• 
The site will attempt to contact the subject and reschedule the missed visit and counsel the 
subject on the importance of maintaining the assigned visit schedule and ascertain if the subject 
wishes to and/or should continue in the study. 
• 
Before a subject is deemed lost to follow-up, the investigator or designee will make every effort 
to regain contact with the subject (where possible, 3 telephone calls, electronic emails or texts 
and, if necessary, a certified letter to the subject’s last known mailing address or local equivalent 
methods). These contact attempts should be documented in the subject’s medical record or 
study file.  
• 
Should the subject continue to be unreachable, he or she will be considered to have withdrawn 
from the study with a primary reason of lost to follow-up.] 
 
7 
STUDY ASSESSMENTS AND PROCEDURES 
 
7.1 
SAFETY AND EFFICACY ASSESSMENTS  
 
 
Inclusion Criteria Assessment 
 
An assessment of accidental bowel leakage and the ability to retain the device is performed as part of 
subject screening.  This assessment includes a questionnaire which asks subjects about bowel leakage 
frequency and intensity.   
 
Daily Bowel Diary Assessment 
 
Subjects will complete a daily bowel diary card on which each subject will be asked to record every 
bowel event.  The card includes a questionnaire onto which subjects will record details relating to bowel 
event cause, stool type, leakage, pain, urgency, medications used, and study device usage.   
 
Weekly Global Fecal Incontinence Assessment 
 
Subjects will complete a weekly questionnaire to assess global fecal incontinence.  The questionnaire 
records subject overall relief of incontinence symptoms each week.   
 
Fecal Incontinence Severity (FISS) Assessment 
 
Subjects will complete a questionnaire to assess fecal incontinence severity (FISS) at the end of the 
baseline period and at the end of the treatment period.  The questionnaire records the severity of 
subject fecal incontinence.   
 

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Fecal Incontinence Quality of Life (FI QOL) Assessment 
 
Subjects will complete a questionnaire to assess fecal incontinence quality of life (FI QOL) at the end of 
the baseline period and at the end of the treatment period.  The questionnaire records the subject 
quality of life in relation to fecal incontinence.   
Patient Reported Outcomes Measurement Information System (PROMIS) Anxiety Assessment 
Subjects will complete a questionnaire to assess their level of anxiety using the PROMIS short form 
instrument Emotional Distress – Anxiety 8a.    
Patient Reported Outcomes Measurement Information System (PROMIS) Depression Assessment 
 
Subjects will complete a questionnaire to assess their level of depression using the PROMIS short form 
instrument Emotional Distress – Depression 8a.    
Credibility/Expectancy Assessment 
Subjects will complete a questionnaire to assess their level of belief that the therapy received will 
reduce their anxiety relating to fecal incontinence.  The questionnaire gathers information relating to 
what each subject thinks will happen during treatment, and what each subject feels will happen during 
treatment.   
User Satisfaction Assessment 
 
Subjects will complete a Quebec User Evaluation of Satisfaction with assistive Technology (QUEST) 
questionnaire to assess their level of satisfaction with the study device.  The questionnaire gathers 
information relating to user satisfaction with various aspects of the device and service provided during 
treatment.   
 
Exploratory Study Assessments: 
 Procedures (for 
sub-study subjects only) 
A schema and rationale for the 
 is as follows.   
 
 
Table 1. Schedule of Events – 
. 
Steps 
Purpose 
i) 
 will be performed if this not been 
performed previously* 
- 
ii)
 
 and randomize 
subjects, equally 
 to one 
i) Evaluate for 
 
 
ii) Evaluate device
 
 
 

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After 
, the anal 
 
 in conjunction with a
  
 will be categorized 
 
).   
(ii) 
 test 
 randomize subjects, 
equally (i.e., 
 each) to one of groups: 
 Minnesota Medical Technologies Anal 
Insert device (10 mm), and Minnesota Medical Technologies Anal Insert device (13 mm).  In the 
 
 group, 
, in 
 
 device.  Then, apply 
.  
Measure 
.  Then, 
 
.  Ask subjects 
 as follows: 
, 
 
, and 
.  Now 
 and measure 
.  Remove subject 
, 
, and 
.  
 after 
reporting 
. 
(iii) 
Anal 
 rectum  
 rectum and 
. The 
.  Thereafter, subjects should be 
 
. [
 the device in situ].  A 
 
will be documented by measuring 
     
(iv) 
Evaluate 
 the device 
Subjects should 
.  Add the anal insert device, randomizing subjects to 
10mm or 13mm device.  Then 
 
.  
 will be measured with a 
 
   
 
(v) 
Subjects will be asked to 
 
If the insert device was 
, document if the device is 
.  If it 
was 
, ask subjects to 
.  
Assessment: 
 
 
This will be performed in all subjects at baseline unless this had been performed within 6 months prior 
to consent.  
) will be performed using established 
validated approaches that our used in our clinical practice and research studies.  After 
 

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with 
 will be 
assessed using standard and established techniques in 
  
 will be 
measured 
 by 
 
.  Since clinical observations suggest that 
 
, 
 will also be assessed.  
Anoscopy will also be performed for subjects who complain of new anorectal bleeding or moderate or 
severe pain on the bowel diary.  After the treatment period, all individuals who withdraw for reasons 
other than personal preference (i.e., for medical reasons) and a minimum of 50% of all patients shall 
undergo an evaluation by anoscopy following the treatment period to assess for device related trauma 
 
Assessment: 
 
 
This test will be done in all subjects either just prior to 
 or during the initial visit in 
subjects who 
.  Similar to ongoing studies in 
, we propose to use 
), which is a 
 comprised of 
 
 is used to 
.  It is FDA 
cleared (FDA K
) for 
 with an 
  The 
 
 and the 
.  The 
 of the 
 when 
 and the 
.  We propose to 
 under 
 during the rectal examination. Once the 
, the 
 will be 
 into the rectum and the 
. This will 
 
. The 
 will be 
 in the 
 with the 
 
. The 
 then be 
.   
 
Assessment: 
 
1. 
: 
 will be used 
to 
.  This will be 
 
as described in literature .  The 
 
 will be calculated by 
 
.  
 will be 
 with subject 
 and a 
 to assess 
 
. 
2. 
 analysis: 
 will be 
 
 using standardized methods 
].  
 of the 
will be
 
 
which has been validated for use 
 and is one of the methods of choice for 
 
.  With the 
 will include both 
the 
 analysis [
].  
 of the 
 will be 
 using 
, which 
has been validated for standard use by 
.  The 
 will 

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ensure 
.  
 will yield 
, ensuring 
) and 
 
).  Identifying 
 
 data.  In 
order to accomplish this task we will follow protocols that we have quantitatively shown to be optimal.  
 using our 
) that has been 
 
.  
will be 
 
 
.  
 be used to 
 that will be used in 
.  
Second,
will be 
 
 following published protocols [
].  Similarly, 
 will be 
 
.  The 
 will be 
 
.  Subsequent 
 
may also be performed. 
3.  
Assessment: 
 will be assessed at baseline using a 
 
) (
).  
This questionnaire is based on the 
 and has been adapted by 
in an 
electronic computer-administered format to evaluate 
 over a three month period.  It 
employs the 
 database for 
.  The 
 been 
validated and compares well with 
 
 
 .  (ii) Subjects will 
 prior to 
 analysis.  The 
 will be analyzed for 
 
 staff using the 
 
 developed by 
.   
4. 
 analysis.  Mayo Clinical is currently exploring
 
  Towards our long-term objective of 
 
, we propose to 
 study subjects.  The 
will 
be
 
.  The 
 will be 
.  
 
.  
 will be conducted 
 
or comparable approaches.  All subjects who qualify for the study based on 
physician assessment in Period 1 
.  
 will be 
examined using these subjects and 
. 
5. Analysis of 
.  In order to investigate 
 
, 
we will 
 at Mayo Clinic 
Rochester.  We will 
at the time of the initial visit.  
 
.  Further 
 
will be 
 at Mayo Clinic, Rochester.  

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Summary of 
.  The 
 for this study 
.   
Item 
Test ID 
Lab 
)  
 
 
 
Use 
) 
 and 
 
 
 
) 
 
 
7.2 
SAFETY AND OTHER ASSESSMENTS 
 
The following procedures/evaluations will be performed for safety assessments: 
• 
Screening visit – Review of medical history, physical examination (including rectal examination) 
following consent, vital signs [ie, temperature, pulse, and blood pressure), height and weight 
• 
Assess adherence to intervention. Inquire about adverse events with phone calls during the 
fitting and treatment periods.   
• 
Review medical records prior to and during study participation for adverse events.  This process 
will adhere to Health Insurance Portability and Accountability Act (HIPAA) rules, other relevant 
federal or state laws, and local institutional requirements should be followed, as applicable.    
• 
Administer questionnaires and a daily diary to record subject-reported outcomes 
• 
Assessment of adverse events. Adverse events will be evaluated promptly.  Subjects will be 
referred for additional tests and/or provided treatment.   
   
7.3 
ADVERSE EVENTS AND SERIOUS ADVERSE EVENTS 
 
7.3.1 DEFINITION OF ADVERSE EVENTS (AE) 
Utilizing ISO 14155:2011, an adverse event (AE) is 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.  An adverse event (also 
referred to as an adverse experience) can be associated with the use of a device, without any judgment 
about causality.   
NOTE 1 This definition includes events related to the investigational medical device or the comparator, if 
applicable. 
NOTE 2 This definition includes events related to the procedures involved. 
NOTE 3 For users or other persons, this definition is restricted to events related to investigational 
medical devices. 
 
7.3.2 DEFINITION OF SERIOUS ADVERSE EVENTS (SAE)  
 
Adverse event that: 
a) Led to death, 

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b) Led to serious deterioration in the health of the subject, that either resulted in 
1) a life-threatening illness or injury, or 
2) a permanent impairment of a body structure or a body function, or 
3) in-patient or prolonged hospitalization, or 
4) medical or surgical intervention to prevent life-threatening illness or injury or permanent 
impairment to a body structure or a body function, 
c) Led to fetal distress, fetal death or a congenital abnormality or birth defect 
NOTE Planned hospitalization for a pre-existing condition, or a procedure required by the CIP, without 
serious deterioration in health, is not considered a serious adverse event. 
 
7.3.3 CLASSIFICATION OF AN ADVERSE EVENT 
 
7.3.3.1 SEVERITY OF EVENT 
AEs will be graded according to the severity of the AE and ranges from Grade 1 (mild AE), Grade 2 
(moderate AE), Grade 3 (severe AE) and Grade 4 (life-threatening or disabling AE) to Grade 5 (death 
related to AE). 
Adverse events will be graded as follows: 
- 
Mild: discomfort noticed but no disruption of normal daily activity. 
- 
Moderate: discomfort sufficient to reduce or affect daily activity. 
- 
Severe: inability to work or perform normal daily activity. 
- 
Life threatening:  represents an immediate threat to life. 
 
Relationship to study device and/or procedure will be determined by the Investigator according to the 
following criteria. 
- 
None:  No relationship between the event and the administration of study device.  The event is 
related to other etiologies, such as concomitant medications or subject’s clinical state. 
- 
Unlikely:  The current state of knowledge indicates that a relationship to study device is unlikely 
or the temporal relationship is such that study device would not have had any reasonable 
association with the observed event. 
- 
Possible:  A reaction that follows a plausible temporal sequence from administration of the 
study device and follows a known response pattern to the suspected study device.  The reaction 
might have been produced by the subject’s clinical state or other modes of therapy 
administered to the subject. 

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- 
Probable:  A reaction that follows a plausible temporal sequence from administration of the 
study device and follows a known response pattern to the suspected study device.  The reaction 
cannot be reasonably explained by the known characteristics of the subject’s clinical state or 
other modes of therapy administered to the subject. 
 
7.3.3.2 RELATIONSHIP TO STUDY INTERVENTION 
 
For the purpose of safety analyses, all AEs that are classified as unlikely, possible, or probable will be 
considered treatment-related events. 
 
7.3.3.3 ANTICIPATED ADVERSE EVENTS   
Anticipated risks for this study include: 
• 
Mild discomfort 
• 
Unexpected expulsion of the device 
• 
New onset, or, if pre-existing, increased anorectal pain or discomfort 
• 
Diarrhea 
• 
Abdominal pain 
• 
Anorectal irritation, pain, soreness 
• 
Rectal, anal, or perianal infection 
• 
Device over-insertion or device migration into anal canal or rectum 
• 
Injury to anus, anal canal, or rectum 
• 
New onset, or, if pre-existing, increased anorectal urge 
• 
New onset, or, if pre-existing, increased abdominal gas 
• 
New onset, or, if pre-existing, increased hemorrhoids or rectal bleeding 
• 
New onset, or, if pre-existing, increased colonic obstruction or fecal impaction 
• 
Perforation of anal canal or rectum 
• 
Device breakage 
• 
Discomfort, bruising, redness, swelling, bleeding around the site of the blood draw 
• 
Feeling of lightheadedness when blood is drawn 
• 
Infection at the site of the blood draw 
• 
Rectal bleeding due to rectal catheter use 
 
There may be additional risks to subjects or embryos or fetuses in women who are of childbearing 
potential that are not known at this time. 
7.3.4 TIME PERIOD AND FREQUENCY FOR EVENT ASSESSMENT AND FOLLOW-UP 

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Adverse events will be recorded from Screening through study exit.  Adverse events should be assessed 
and reported to the sponsor from enrolment through resolution or study exit, whichever comes first.   
Subjects should continue to be followed per standard of care after study exit.    
 
7.3.5 ADVERSE EVENT REPORTING  
Each subject must be carefully monitored for the development of any adverse events.  This information 
should be obtained in the form of non-leading questions (e.g., “How are you feeling?”) and from signs 
and symptoms detected during each examination, observations of study personnel, and spontaneous 
reports from subjects. 
 
All adverse events (serious and non-serious) spontaneously reported by the subject and/or in response 
to an open question from study personnel or revealed by observation, physical examination or other 
diagnostic procedures will be recorded in the source documentation and on the appropriate page of the 
CRF.  Any clinically relevant deterioration in laboratory assessments or other clinical findings is 
considered an adverse event and must be recorded on the appropriate pages of the CRF.  When 
possible, signs and symptoms indicating a common underlying pathology should be noted as one 
comprehensive event. Participants who have a T score ≥ 70 on the PROMIS depression instrument will 
be managed according to the flow diagram immediately after Section 11, References. 
 
7.3.6 REPORTING UNANTICIPATED PROBLEMS INVOLVING RISKS TO SUBJECTS OR 
OTHERS (UPIRTSOS) 
 
Adverse Event reporting will follow the Mayo Clinic IRB policy for submitting reportable events. 
Consistent with this policy, “an UPIRTSO  is defined as any problem or event which, in the opinion of the 
local Investigator, meets all reporting criteria for events that are serious, unanticipated and related (at 
least “possibly” related) to research procedures or the study device, as noted in protocol section 7.4.1.   
 
The Principal Investigator must report internal UPIRTSOs to the IRB, using the IRB electronic Reportable 
Event form, within five working days of the PI or study team becoming aware of the problem or event.  
Reportable events having the potential to meet the UPIRTSO criteria will be forwarded to the IRB. An IRB 
Chairperson has the authority to determine that the criteria were not met. If the IRB Chairperson 
considers the event to be a UPIRTSO it must be reviewed by a convened IRB. The investigator is notified 
in writing. The review, determination, and relevant communication is documented in the IRB electronic 
system.  A UPIRTSO, as determined by the convened IRB, is reported to the Mayo Clinic Institutional 
Official and relevant federal agencies, when required, within 30 days from the date of IRB 
determination. The investigator is notified in writing of this action. 
The timing of investigator reporting of protocol violation/deviations to the IRB, using the IRB 
electronic Reportable Event form, is dependent on the severity of the protocol violation/deviation. 
Major protocol violations/deviations that affect the rights and welfare of subjects and others, increase 
risks to subjects and others, decrease potential benefits, compromise the integrity or validity of the 

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research; or represent willful or intentional misconduct must be reported by the investigator within five 
working days of the PI or study team becoming aware of the violation/deviation.  Minor protocol 
violations and/or deviations should be summarized and submitted to the IRB at the time of continuing 
review. 
Information that indicates a significant new serious risk or increased severity of known risk, or a 
safety issue which requires immediate action must be reported to the IRB using the IRB electronic 
Modification form, within five working days of the PI or study team becoming aware of the information. 
The modification must be titled Urgent Action Required and include the Subject Notification Form 
attachment.  The investigator is responsible to review new information to determine if it meets the 
above criteria for immediate action. 
 
If IRB reporting requirements change during the study, the most current IRB reporting policies will be 
followed. 
All SAEs must be reported whether or not considered causally related to the study device.  SAE forms 
will be completed and the information collected will include subject number, a narrative description of 
the event and an assessment by the Investigator as to the severity of the event and relatedness the to 
study device.  Follow-up information on the SAE may be requested by Minnesota Medical Technologies 
or designee. 
 
Contact Information: 
 
Minnesota Medical Technologies 
2446 Henry Road NW 
Stewartville, MN  55976 USA 
 
Fax: 
 
 
Preferred method of contact is by email: 
 
 
Follow-Up SAE Reports: 
The Investigator must continue to follow the subject until the SAE has resolved or until the condition 
becomes chronic in nature, stabilizes (in the case of persistent impairment) or the subject dies. 
Within 24 hours of receipt of follow-up information, the Investigator must update the SAE form for the 
study and submit any supporting documentation (e.g., subject discharge summary or autopsy reports) 
via fax or e-mail. 
 

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For both serious and non-serious adverse events, the Investigator must determine the severity, 
anticipatedness, and the relationship of the event to study device and/or study procedure.   
 
7.3.7 REPORTING EVENTS TO PARTICIPANTS  
 
Any information which could impact a subject’s decision to participate in the study will be 
communicated to them in writing.  
 
7.3.8 EVENTS OF SPECIAL INTEREST  
Anoscopy will be performed for subjects who complain of new anorectal bleeding or moderate or severe 
pain on the bowel diary.  After the treatment period, all individuals who withdraw for reasons other 
than personal preference (i.e., for medical reasons) and a minimum of 50% of all patients shall undergo 
an evaluation by anoscopy following the treatment period to assess for device related trauma 
If signs of a major side effect (e.g., rectal perforation) should occur, the subject will be treated as 
clinically indicated and Principal Investigator and Sponsor will be notified immediately.  Such events 
should be reported on the case report form.  Unanticipated serious adverse events will be immediately 
reported to the sponsor. 
A device deficiency is defined as inadequacy of a medical device with respect to its identity, quality, 
durability, reliability, safety or performance.  Device deficiencies include malfunctions, use errors, and 
inadequate labelling. 
A malfunction is defined as a failure of an investigational medical device to perform in accordance with 
its intended purpose when used in accordance with the instructions for use or clinical protocol. 
If a device deficiency or device malfunction is noted, this will be immediately reported by the site to the 
sponsor. 
7.3.9 REPORTING OF PREGNANCY  
 
Reports of pregnancy should be communicated by the site to the study sponsor immediately.  
 
7.4 
UNANTICIPATED PROBLEMS 
 
7.4.1 DEFINITION OF ANTICIPATED AND UNANTICIPATED ADVERSE EVENTS, 
UNANTICIPATED PROBLEM (UP)  
 
Per ISO 14155:2011, an anticipated serious adverse device effect (ASADE) is an effect which by its 
nature, incidence, severity or outcome has been identified in the risk analysis report. 
 

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Per ISO 14155:2011, unanticipated serious adverse device effect (USADE) IS A serious adverse device 
effect which by its nature, incidence, severity or outcome has not been identified in the current version 
of the risk analysis report.  Per 21 CFR 812, If there are serious, unexpected adverse reactions associated 
with the use of the study device, Minnesota Medical Technologies or designee will notify the 
appropriate regulatory agency(ies) and all participating investigators on an expedited basis.  An 
unanticipated serious adverse device effect (USADE) is a serious adverse device effect which by its 
nature, incidence, severity or outcome has not been identified in the current version of the risk analysis 
report.  It is the responsibility of the Investigator and sponsor to promptly notify the Institutional Review 
Board (IRB) of all unexpected serious adverse device reactions involving risk to human subjects.  A 
sponsor who determines that an unanticipated adverse device effect presents an unreasonable risk to 
subjects shall terminate all investigations or parts of investigations presenting that risk as soon as 
possible. Termination shall occur not later than 5 working days after the sponsor makes this 
determination and not later than 15 working days after the sponsor first received notice of the effect.  
The sponsor shall report the results of such USADE evaluation to FDA and to all reviewing IRBs 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. 
 
In accordance with the Institutional Review Board (IRB) at Mayo Clinic, an unanticipated problem 
involving risk to subjects or others (UPIRTSO) will be defined any problem or event which, in the opinion 
of the Investigator meets all three of the following criteria: 
• Serious: Problem or event that resulted in significant harm, (which may be physical, psychological, 
financial, social, economic, or legal) or place the subjects or others at a greater risk of harm than was 
previously known or recognized. Note that actual harm need not have occurred. 
• Unanticipated: A problem or event that was unforeseeable at the time of its occurrence and meets 
one or more of the following criteria:  
- 
Not already described as a potential risk in the approved informed consent  
- 
Not already described as a potential risk in the approved protocol  
- 
Not listed in the Investigator’s Brochure  
- 
Not part of an underlying disease  
- 
Occurred at an increased frequency or at an increased severity than expected.  
• Related: A problem or event is "related" if it is possibly related to the research procedures.  
 
7.4.2  UNANTICIPATED PROBLEM REPORTING  
 
All UPIRTSOs will be reported to the study Sponsor and the Mayo Clinic IRB who will decide whether the 
event(s) should be reported to regulatory agencies (e.g., OHRP, FDA, etc).   
 
7.4.3 REPORTING UNANTICIPATED PROBLEMS TO PARTICIPANTS  
 
Subjects will be notified about any significant or new information which could impact their decision to 
participate in the study.  This may include unanticipated problems. 
 
8 
STATISTICAL CONSIDERATIONS  
 

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8.1 
STATISTICAL HYPOTHESES 
The hypotheses for the primary endpoints, which all apply to subjects with FI, are indicated below.  For 
the primary study, these endpoints will be assessed for all 60 participants and separately for the 10 mm 
and 13 mm devices (versus baseline).   
 
1.  Primary    Effectiveness Endpoint: A Relative Percentage Change in Episodes of Accidental Bowel 
Leakage (ABL) Determined by Comparing Treatment Results to Pre-treatment Results 
From the Baseline Period as Measured by Daily Diary Recordings .   [Time Frame: 
Reduction in accidental bowel leakage from Baseline (Weeks 1-4) through Treatment 
period (approximately Weeks 9-12).   
 
Measure Type 
Primary 
Measure Title 
Primary Effectiveness Endpoint: A Relative Percentage Change in Episodes of 
Accidental Bowel Leakage (ABL) Determined by Comparing Treatment Results to 
Pre-treatment Results From the Baseline Period as Measured by Daily Diary 
Recordings. 
Measure Description 
This primary effectiveness endpoint will be calculated as a relative percentage 
of the baseline Accidental Bowel Leakage (ABL) using the following equation: % 
reduction in ABL = 100*(baseline period ABL - treatment period ABL) / (baseline 
period ABL) 
Time Frame 
Reduction in accidental bowel leakage from Baseline (Weeks 1-4) through 
Treatment period (approximately Weeks 9-12).   
 
 
Secondary Efficacy Endpoint(s):  
- 
The mean % reduction in Fecal Incontinence Severity Index (FISS) score from the baseline period 
to the end of the treatment period, calculated according to the following equation: % reduction 
in FISS  = 100% (baseline period FISS - end treatment period FISS) /  (baseline period FISS).   
- 
The proportion of subjects in whom the frequency of FI episodes during the treatment period is 
greater than or equal to 75% lower than the frequency observed during baseline period.   
- 
The proportion of subjects in whom, during treatment period, the device will reduce the 
number of days with FI by 50% as compared to baseline. 
- 
The proportion of subjects in whom the device will reduce the volume of FI during the 
treatment period as compared to baseline. 
- 
The proportion of subjects in whom the Minnesota Medical Technologies Anal Insert Device 
reduces the proportion of FI episodes which are associated with diarrhea. 
- 
The proportion of subjects in whom the Minnesota Medical Technologies Anal Insert Device 
reduces the number of episodes of passive and of urge FI 
- 
The proportion of subjects in whom the Minnesota Medical Technologies Anal Insert Device l 
improves the Quality of Life (QOL) related to FI during the treatment period as compared to 
baseline. 

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- 
The proportion of subjects in whom the Minnesota Medical Technologies Anal Insert Device will 
affect the composition of stool leakage during the treatment period as compared to baseline. 
- 
The proportion of subjects are satisfied with the Minnesota Medical Technologies Anal Insert 
Device. 
- 
The time for which a bowel movement can be deferred after the occurrence of urgency will be 
affected by the Minnesota Medical Technologies Anal Insert Device. 
- 
The proportion of complete bowel movements will be affected by the Minnesota Medical 
Technologies Anal Insert Device during the treatment period as compared to baseline. 
- 
Treatment with the Minnesota Medical Technologies Anal Insert Device will affect anxiety and 
depression during the treatment period as compared to baseline. 
- 
The Minnesota Medical Technologies Anal Insert Device reduces the use of medications for FI 
during the treatment period as compared to baseline. 
- 
 
. 
- 
 
.   
 
8.2 
SAMPLE SIZE DETERMINATION 
 
The sample size determination was based on literature review.  In a controlled clinical trial with 
clonidine, the mean and standard deviation (SD) for weekly FI episodes over a 4 week baseline period 
was 2.642 and 1.066 respectively in the placebo group.29  
Assuming a mean frequency of 2.6 and a very conservative estimated SD of differences (post-pre 
treatment) of 1.3, a sample size of 13 subjects provides 90% power with a two sided paired t test and an 
alpha level of 0.05 to detect a 50% reduction (i.e., from 2.6 to 1.3 episodes/week) in the number of 
episodes of FI.  Hence, a sample size of 30 FI subjects per group (i.e., 10mm and separately 13 mm 
inserts) is more than sufficient. 
In order to test whether the treatment provides an improvement up to 60% response rate (50% 
response) from an assumed historical rate of 30%, the exact one-sample binomial test (2-sided) will be 
used at the 0.05 level.  A sample size of n=30 provides 90% power to detect this effect.   
No previous studies have evaluated 
.  We estimated that FI 
subjects 
 will 
) of the 
).  If 
 with a sample size of 
 in the 
 and 
 in the 
 (i.e., 
 devices), provides 
 
 
. 

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detailed methods for the analyses outlined below, 
All bowel diary parameters (e.g., stool frequency, form, urgency, use of rescue medications, and FI) will 
be averaged first for each day and then over 4 weeks (baseline period and the last 4 of 12 weeks 
(approximately Weeks 9-12, treatment period) in each subject.  These responses will also be assessed 
using ANCOVA models, with the corresponding baseline value as the primary covariate.  [During the 
fitting period (approximately weeks 5-8), bowel diaries and questionnaires will be maintained to 
determine the right size of device.  However, these data will not be used to evaluate the efficacy of the 
device.]  
The analyses of the primary and secondary quantitative endpoints will utilize analysis of covariance 
(ANCOVA) models using corresponding baseline measurements, if available, as covariates.  The 
adequate relief endpoint will first be summed over 4 treatment weeks, and then assessed using the 
Wilcoxon rank sum test.  Treatment effects between groups (i.e., 10 mm vs 13 mm) will be evaluated, as 
appropriate with ANCOVA adjusted for the baseline variable. Individual adverse events (AEs) will be 
summarized and, where appropriate, (i.e., for parameters that are recorded during baseline and 
treatment bowel diaries such as pain during defecation), the overall frequency of AEs be compared 
using the Wilcoxon rank sum test.  For the volume of FI episodes, a weighted score will be computed as 
follows (proportion of minor episodes*2 + proportion of major episodes*3).25  An FI episode is defined 
as any episode of stool leakage that is more than a stain.  A “minor FI episode” is more than a stain but 
not an entire bowel movement.  A “major FI episode” is an entire bowel movement.    
 
8.4.3 ANALYSIS OF THE SECONDARY ENDPOINT(S) 
See section 9.4.2 
 
8.4.4 SAFETY ANALYSES 
 
Safety endpoints (e.g., adverse events, serious adverse events, unanticipated serious adverse events, 
device deficiencies, and device malfunctions) will be analyzed and reported with summary statistics.   
The start date, stop date, severity, relationship, expectedness, outcome, and duration of each AE will be 
reported.  Adverse events leading to premature discontinuation from the study intervention and serious 
treatment-emergent AEs will be presented either in a table or a listing.   
 
8.4.5 BASELINE DESCRIPTIVE STATISTICS 
 
The intervention groups will be compared on baseline characteristics, including demographics and 
clinical features using descriptive statistics.  
 

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8.4.6 PLANNED INTERIM ANALYSES  
 
There are no planned interim analysis for this study. 
 
8.4.7 SUB-GROUP ANALYSES 
 
Data for the primary endpoint will be evaluated separately in men and women, and also separately in 
younger and older subjects.  The precise age cut off will depend on the distribution of subjects. Data for 
the secondary endpoints will be analyzed likewise.  
 
8.4.8 TABULATION OF INDIVIDUAL SUBJECT DATA 
If appropriate, individual subject data will be listed by measure and time point in the figures. 
 
 
8.4.9 EXPLORATORY STUDY AND ANALYSES 
STUDY 
For the EXPLORATORY study, the 
 
, will be compared between both device groups  (i.e, 10 and 
13 mm) 
 
  Similarly, 
 10 and 13 mm devices will be 
compared 
.  The relationship between 
 
 will be compared 
.  Linear regression models will 
evaluate 
.  The 
 will be one or more of the 
following variables: 
 
.  The anal 
, proportion of subjects 
 
) and anorectal
 
) will be summarized.       
ANALYSIS 
 will be anonymized before being 
 
.  These results 
.    
 will 
 
Mayo Clinic 
 Mayo Clinic or at other institutions.  
. 
The exploratory objectives are to: 
- 
Evaluate the effects of the Minnesota Medical Technologies Anal Insert Device 
 
, as measured with 
 
- 
Evaluate if the effects of the Minnesota Medical Technologies Anal Insert Device 
 
 
the Minnesota Medical Technologies Anal 
Insert device 
 
- 
Evaluate the 
 subjects with FI 

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- 
Investigate 
 associated with FI 
 
obtained at baseline 
 
9 
SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS 
 
9.1 
REGULATORY, ETHICAL, AND STUDY OVERSIGHT CONSIDERATIONS 
 
9.1.1 INFORMED CONSENT PROCESS 
 
9.1.1.1 CONSENT/ASSENT AND OTHER INFORMATIONAL DOCUMENTS PROVIDED TO SUBJECTS 
 
This study will be conducted in compliance with 21 CFR Parts 11, 50, 54, 56 and 812.  The consent form 
is provided under separate cover. 
 
9.1.1.2 CONSENT PROCEDURES AND DOCUMENTATION 
 
Informed consent is a process that is initiated prior to the individual’s voluntary documented agreement 
to participate in the study. Informed consent forms will be developed by the study sponsor together 
with the study site in a language and reading level understandable by the subject, reviewed by an 
accredited Institutional Review Board (IRB) and approved by the IRB prior to use. Each potential study 
subject will be asked to read and review the document. The investigator or designee will explain the 
research study to the subject and ensure enough time to answer any questions that may arise. The 
subjects should have the opportunity to discuss the study with their family or surrogates or think about 
it prior to agreeing to participate. The subject will sign and date the informed consent document prior to 
any procedures being done specifically for the study. Subjects must be informed that participation is 
voluntary and that they may withdraw from the study at any time, without prejudice, penalty, or loss of 
benefits. A copy of the informed consent document will be given to the subjects for their records. The 
informed consent process will be conducted and documented in the source document (including the 
date), and the form signed and dated, before the subject undergoes any study-specific procedures. The 
rights and welfare of the subjects will be protected by emphasizing to them that the quality of their 
medical care will not be adversely affected if they decline to participate in this study. 
 
9.1.2 STUDY DISCONTINUATION AND CLOSURE 
This study may be prematurely terminated, if in the opinion of the IRB, Investigator, or Minnesota 
Medical Technologies, there is sufficient reasonable cause.  Written notification documenting the reason 
for study termination will be provided to the Investigator or Minnesota Medical Technologies by the 
terminating party.  Appropriate notification to the IRB will be ensured by the study site and sponsor. 
Circumstances that may warrant termination include, but are not limited to: 
- 
Determination of unexpected, significant, or unacceptable risk to subjects. 

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- 
Insufficient complete and/or evaluable data. 
- 
Plans to modify, suspend or discontinue the development of the study device. 
Should the study be closed prematurely, all study materials must be returned to Minnesota Medical 
Technologies or designee. 
9.1.3 CONFIDENTIALITY AND PRIVACY  
 
Subject confidentiality and privacy is strictly held in trust by the participating investigators, their staff, 
and the sponsor(s) and their interventions. This confidentiality is extended to cover 
 
 in addition to the clinical information relating to subjects. Therefore, the study 
protocol, documentation, data, and all other information generated will be held in strict confidence. No 
information concerning the study or the data will be released to any unauthorized third party without 
prior written approval of the sponsor.  
 
All research activities will be conducted in as private a setting as possible. 
 
The study monitor, other authorized representatives of the sponsor, representatives of the Institutional 
Review Board (IRB), regulatory agencies or company supplying study product may inspect and copy all 
documents and records required to be maintained by the investigator, including but not limited to, 
consent forms, study regulatory documents, medical records (office, clinic, or hospital) and pharmacy 
records for the subjects in this study. The clinical study site will permit access to such records. 
 
The study subject’s contact information will be securely stored at each clinical site for internal use 
during the study. At the end of the study, all records will continue to be kept in a secure location for as 
long a period as dictated by the reviewing IRB, Institutional policies, or sponsor requirements, for at 
least two years after the data is no longer needed to support the marketing application. 
 
 
9.1.4 FUTURE USE OF 
 DATA  
Data collected for this study will be analyzed and stored at Mayo Clinic for future research.  The study 
team will use 
 study analysis at present time and with further 
consent from subjects for future research.  If subjects agree to give future permission of 
, 
they will then become the property of Mayo Clinic.  Other researchers at Mayo Clinic who are not 
involved with this study and researchers at other institutions may ask 
 for future 
research.  The 
 will be sent to researchers in a coded format, which protects their 
identity.  Some future studies may examine 
 and subjects may be contacted by the 
Principal Investigator if there are findings deemed useful to the subject, with consideration of the 
potential risks, benefits, and costs of choosing to learn about the findings.  Finally, subjects will be asked 
for individual consent on the use 
 for future research (i) on fecal incontinence and 
defecatory disorders, (ii) on other health problems, and iii) permission to 
 to researchers at 
other institutions.  
During the conduct of the study, an individual subject can choose to withdraw consent to have 
 
 for future research.  However, withdrawal of consent with regard to 
 

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Before study initiation, the applicable Good Clinical Practice (GCP), FDA regulations, investigator 
responsibilities, the study protocol, safety reporting requirements, monitoring and auditing procedures, 
data collection procedures, case report form completion, possibility of FDA inspection, and other study 
requirements will be reviewed with the investigators and their staff.  The investigator is responsible for 
ensuring protocol and GCP compliance for the integrity of the site’s data and study conduct.  An 
independent site monitor will visit the site to assess compliance to the regulations, IRB conditions of 
approval, the study protocol, and other study requirements.  The monitor will assess the accuracy and 
completeness of entries on the Case Report Forms (CRFs), the adherence to the protocol and to Good 
Clinical Practice, the progress of enrollment, and to ensure that the study device is being stored, 
dispensed, and accounted for according to specifications.  Key study personnel must be available to 
assist the monitor during these visits.  The investigator must maintain source documents for each 
subject in the study, consisting of case history and visit notes (hospital or clinic medical records) 
containing demographic and medical information, laboratory data, and the results of any other tests or 
assessments.  All information on CRFs must be traceable to these source documents in the subject's file.  
The investigator must also keep the original informed consent form signed by the subject (a signed copy 
is to be given to the subject).  The investigator must give the monitor access to all relevant source 
documents to confirm their consistency with the CRF entries.  The Minnesota Medical Technologies 
designated study site monitor will follow the study monitoring plan requirements.   
Additional checks of the consistency of the source data with the CRFs are to be performed according to 
the study-specific monitoring plan.  No information in source documents about the identity of the 
subjects will be disclosed. 
 
9.1.8 QUALITY ASSURANCE AND QUALITY CONTROL 
 
Quality control (QC) procedures will be implemented, including within the data entry system.  Data edit 
checks will be run on the validated database, and any missing data or data anomalies will be 
communicated to the site(s) for clarification/resolution via queries which will include an audit trail and 
be maintained on file. 
 
Following written Standard Operating Procedures (SOPs), the monitors will verify that the clinical trial is 
conducted and data are generated and biological specimens are collected, documented (recorded), and 
reported in compliance with the protocol, FDA regulations in 21 CFR Parts 11, 50, 54, 56, and 812.  
 
The investigational site will provide direct access to all trial related sites, source data/documents, and 
reports for the purpose of monitoring and auditing by the sponsor, and inspection by local and 
regulatory authorities. 
 
 
9.1.9 DATA HANDLING AND RECORD KEEPING  
Database management and quality control 
All data should be recorded, handled and stored in a way that allows its accurate reporting, 
interpretation and verification.  The clinical study monitor will review the data entered into the eCRFs by 

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investigational staff for completeness and accuracy and instruct the site personnel to make any required 
corrections or additions.  Queries will be sent to the investigational site using an electronic data query. 
Designated investigator site staff is required to respond to the query and confirm or correct the data.  If 
the electronic query system is not used, a paper Data Query Form will be provided to the site. Site 
personnel will complete, sign, and date the paper query, then scan and return to the sponsor via email 
or provide to the sponsor in person.  If a paper query must be used, the study monitor who will make 
the correction to the database and will reference the paper query as the source of the data entry.  The 
paper query form(s) will be maintained at the site and also in the sponsor trial master file. 
 
9.1.9.1 DATA COLLECTION AND MANAGEMENT RESPONSIBILITIES  
Data collection is the responsibility of the clinical trial staff at the site under the supervision of the site 
investigator. The investigator is responsible for ensuring the accuracy, completeness, legibility, and 
timeliness of the data reported. 
 
All source documents should be completed in a neat, legible manner to ensure accurate interpretation 
of data.   
 
Hardcopies of the study visit worksheets may be provided for use as source document worksheets for 
recording data for each subject enrolled in the study.  Data recorded in the electronic case report form 
(eCRF) derived from source documents should be consistent with the data recorded on the source 
document worksheets and medical records.  
 
Clinical data (including adverse events (AEs), concomitant medications, and expected adverse reactions 
data) and clinical laboratory data will be entered into a 21 CFR Part 11-compliant data capture system 
provided by the study sponsor or designee.  The data system is to include unique user IDs, unique 
password protection, audit trails, 21 CFR Part 11 compliance analysis, and internal quality checks, such 
as automatic range checks, to identify data that appear inconsistent, incomplete, or inaccurate.  Clinical 
data will be entered as documented in the source documents. 
 
 
9.1.9.2 STUDY RECORDS RETENTION  
 
The investigator agrees to keep the records and documents that include (but are not limited to) the 
study-specific documents, the identification log of all participating subjects, medical records, source 
worksheets, all original signed and dated informed consent forms, subject authorization forms regarding 
the use of personal health information (if separate from the informed consent forms), paper or 
electronic copy of CRFs, including the audit trail, and detailed records of device disposition and 
accountability to enable evaluations or audits from regulatory authorities, the sponsor or its designees. 
Any source documentation printed on degradable thermal sensitive paper should be photocopied by the 
site and filed with the original in the subject’s chart to ensure long term legibility. Furthermore, the 
investigator is required to retain essential documents until at least 2 years after the last approval of a 
marketing application for a specified drug indication being investigated or, if an application is not 

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approved, until at least 2 years after the investigation is discontinued and regulatory authorities are 
notified. Study records should be retained until an amount of time specified by applicable regulatory 
requirements or for a time specified in the study site agreement between the investigator and sponsor.  
Refer to the study site agreement for the sponsor’s requirements on record retention. The investigator 
should contact and receive written approval from the sponsor before disposing of any such documents. 
 
9.1.10 PROTOCOL DEVIATIONS  
 
The investigator should not deviate from the protocol, except where necessary to eliminate an 
immediate hazard to study subjects.  Should other unexpected circumstances arise that will require 
deviation from protocol-specified procedures, the investigator should consult with the sponsor or 
designee (and IRB, as required) to determine the appropriate course of action. There will be no 
exemptions (a prospectively approved deviation) from the inclusion or exclusion criteria.  The site 
should document all protocol deviations in the subject’s source documents. In the event of a significant 
deviation, the site should notify the sponsor or its designee (and IRB, as required).  Significant deviations 
include, but are not limited to, those that involve fraud or misconduct, increase the health risk to the 
subject, or confound interpretation of primary study assessment.  A Protocol Deviation Form should be 
completed by the site and signed by the investigator and sponsor for any significant deviation from the 
protocol.  A protocol deviation is any noncompliance with the clinical trial protocol, IRB requirements, 
and/or FDA regulations.  The noncompliance may be either on the part of the subject, the investigator, 
or the study site staff.  
 
 
9.1.11 PUBLICATION AND DATA SHARING POLICY 
 
This study will be conducted in accordance with the following publication and data sharing policies and 
regulations: 
 
This trial will be registered at ClinicalTrials.gov, and results information from this trial will be submitted 
to ClinicalTrials.gov.  In addition, every attempt will be made to publish results in peer-reviewed 
journals.   
 
 
9.1.12 CONFLICT OF INTEREST POLICY 
 
The independence of this study from any actual or perceived influence, such as by the pharmaceutical 
industry, is critical.  Therefore, any actual conflict of interest of persons who have a role in the design, 
conduct, analysis, publication, or any aspect of this trial will be disclosed and managed. Furthermore, 
persons who have a perceived conflict of interest will be required to have such conflicts managed in a 
way that is appropriate to their participation in the design and conduct of this trial and in accordance 
with guidance from the Conflict of Interest Review Board at Mayo Clinic.  
 
9.2 
ADDITIONAL CONSIDERATIONS 
Not applicable. 

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9.3 
ABBREVIATIONS 
The list below includes abbreviations utilized in this template.  However, this list should be customized 
for each protocol (i.e., abbreviations not used should be removed and new abbreviations used should be 
added to this list). 
 
AE 
Adverse Event 
ANCOVA 
Analysis of Covariance 
ANSI 
American National Standards Institute 
CDRH 
Center for Devices and Radiological Health 
CLIA 
Clinical Laboratory Improvement Amendments 
CMP 
Clinical Monitoring Plan 
COC 
Certificate of Confidentiality 
CONSORT 
Consolidated Standards of Reporting Trials 
COX-2 
Cyclooxygenase 
CRF 
Case Report Form 
CRF 
Code of Federal Regulations 
CRTU 
Clinical Research and Trial Unit 
CTCAE 
Common Terminology Criteria for Adverse Events 
DCC 
Data Coordinating Center 
DHHS 
Department of Health and Human Services 
DNA 
Deoxyribonucleic Acid 
DRE 
Disease-Related Event 
DSMB 
Data Safety Monitoring Board 
EC 
Ethics Committee 
eCRF 
Electronic Case Report Forms 
EDC 
Electronic Data Capture 
EDTA 
Ethylenediaminetetraacetic acid 
EN 
English 
FDA 
Food and Drug Administration 
FDAAA 
Food and Drug Administration Amendments Act of 2007 
FFQ 
Food Frequency Questionnaire 
FFR 
Federal Financial Report 
FI 
Fecal Incontinence 
FIQOL 
Fecal Incontinence Quality of Life 
FISS 
Fecal Incontinence Symptom Severity 
FMEA 
Failure Mode and Effect Analysis 
GCP 
Good Clinical Practice 
GI 
Gastrointestinal 
GLP 
Good Laboratory Practices 
GMP 
Good Manufacturing Practices 
GWAS 
Genome-Wide Association Studies 
HIPAA 
Health Insurance Portability and Accountability Act  
IBS 
Irritable Bowel Syndrome 
ICH 
International Conference on Harmonization  
ICMJE 
International Committee of Medical Journal Editors 
IRB 
Institutional Review Board 
ISMP 
Institute of Safe Medical Practices 

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ISO 
International Organization for Standardization 
ITT 
Intent to Treat 
MAUDE 
Manufacturer and User Facility Device Experience 
mITT 
modified Intent to Treat 
MMT 
Minnesota Medical Technologies 
MRI 
Magnetic Resonance Imaging 
NCT 
National Clinical Trial 
NSAID 
Non-Steroidal Anti-Inflammatory Drugs 
OHRP 
Office for Human Research Protections 
PD 
Protocol Deviation 
PI 
Principal Investigator 
PROMIS 
Patient Reported Outcomes Measurement Information System 
QA 
Quality Assurance 
QC 
Quality Control 
QOL 
Quality of Life 
QUEST 2.0 
Quebec User Evaluation of Satisfaction with Assistive Technology 
RNA 
Ribonucleic acid 
SAE 
Serious Adverse Event 
SAP 
Statistical Analysis Plan 
SAP 
Statistical Analysis Plan 
SD 
Standard Deviation 
SMC 
Safety Monitoring Committee 
SNP 
Single nucleotide polymorphisms 
SOA 
Schedule of Activities 
SOC 
System Organ Class 
SOP 
Standard Operating Procedure 
UADE 
Unanticipated Adverse Device Effect 
UP 
Unanticipated Problem 
US 
United States 
VS 
Vital Signs 
 
 
 

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9.4 
PROTOCOL AMENDMENT HISTORY 
The protocol amendment history will be included on page 1 of this protocol.  
 

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10 REFERENCES  
1. 
Bharucha AE, Dunivan G, Goode PS, et al. Epidemiology, Pathophysiology, and Classification of 
Fecal Incontinence: State of the Science Summary for the National Institute of Diabetes and 
Digestive and Kidney Diseases (NIDDK) Workshop. American Journal of Gastroenterology 
2015;110:127-136. 
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. 
Bharucha AE, Rao SSC, Shin AS. Surgical Interventions and the Use of Device-Aided Therapy for 
the Treatment of Fecal Incontinence and Defecatory Disorders. Clinical Gastroenterology & 
Hepatology 2017;15:1844-1854. 
4. 
Whitehead WE, Rao SSC, Lowry A, et al. Treatment of Fecal Incontinence: State of the Science 
Summary for the National Institute of Diabetes and Digestive and Kidney Diseases Workshop. 
American Journal of Gastroenterology 2015;110:127-136. 
5. 
Prichard D, Harvey DM, Fletcher JG, et al. Relationship Among Anal Sphincter Injury, Patulous 
Anal Canal, and Anal Pressures in Patients With Anorectal Disorders. Clinical Gastroenterology 
and Hepatology 2015;13:1793-1800. 
6. 
Deutekom M, Dobben A. Plugs for containing faecal incontinence. Cochrane Database of 
Systematic Reviews 2005:CD005086. 
7. 
Lukacz ES, Segall MM, Wexner SD. Evaluation of an Anal Insert Device for the Conservative 
Management of Fecal Incontinence. Diseases of the Colon & Rectum 2015;58:892-8. 
8. 
Richter HE, Matthews CA, Muir T, et al. A vaginal bowel-control system for the treatment of 
fecal incontinence. Obstetrics & Gynecology 2015;125:540-7. 
9. 
Simren M, Barbara G, Flint HJ, et al. Intestinal microbiota in functional bowel disorders: a Rome 
foundation report. Gut 2013;62:159-76. 
10. 
Parthasarathy G, Chen J, Chen X, et al. Relationship Between Colonic vs Fecal Microbiota and 
Symptoms, Colonic Transit, and Methane Production in Female Patients With Chronic 
Constipation. Gastroenterology 2015;In press. 
11. 
Cella D, Riley W, Stone A, et al. The Patient-Reported Outcomes Measurement Information 
System (PROMIS) developed and tested its first wave of adult self-reported health outcome item 
banks: 2005-2008. Journal of Clinical Epidemiology 2010;63:1179-94. 
12. 
Driban JB, Morgan N, Price LL, et al. Patient-Reported Outcomes Measurement Information 
System (PROMIS) instruments among individuals with symptomatic knee osteoarthritis: a cross-
sectional study of floor/ceiling effects and construct validity. BMC Musculoskeletal Disorders 
2015;16:253. 
13. 
Senders A, Hanes D, Bourdette D, et al. Reducing survey burden: feasibility and validity of 
PROMIS measures in multiple sclerosis. Multiple Sclerosis 2014;20:1102-11. 
14. 
Devilly GJ, Borkovec TD. Psychometric properties of the credibility/expectancy questionnaire. 
Journal of Behavior Therapy & Experimental Psychiatry 2000;31:73-86. 
15. 
Bharucha AE, Locke GR, Seide B, et al. A New Questionnaire for Constipation and Fecal 
Incontinence. Alimentary Pharmacology & Therapeutics. 2004;20:355-364. 
16. 
Bharucha AE, Seide B, Fox JC, et al. Day-to-day Reproducibility of Anorectal Sensorimotor 
Assessments in Healthy Subjects. Neurogastroenterology & Motility. 2004;16:241-50. 
17. 
Bharucha AE, Fletcher JG, Harper CM, et al. Relationship between symptoms and disordered 
continence mechanisms in women with idiopathic fecal incontinence. Gut. 2005;54:546-55. 

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18. 
Bharucha AE, Fletcher JG, Seide B, et al. Phenotypic variation in functional disorders of 
defecation. Gastroenterology 2005;128:1199-1210. 
19. 
Bharucha AE, Fletcher JG, Melton LJ, 3rd, et al. Obstetric trauma, pelvic floor injury and fecal 
incontinence: a population-based case-control study. Am J Gastroenterol 2012;107:902-11. 
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Effects of the Minnesota Medical Technologies Anal Insert Device in Fecal Incontinence 
 
 
Version 7.0 
Protocol Number IRB-18-004642 
24February2023 
CONFIDENTIAL  Page 66 of 72 total number of pages includes protocol pages and table of contents 
 
 
 
 
Management of Depression: 
 
 
 
 
 

Effects of the Minnesota Medical Technologies Anal Insert Device in Fecal Incontinence 
 
 
Version 7.0 
Protocol Number IRB-18-004642 
24February2023 
CONFIDENTIAL  Page 67 of 72 total number of pages includes protocol pages and table of contents 
 
 
Study Informed Consent 
(provided under separate cover) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Effects of the Minnesota Medical Technologies Anal Insert Device in Fecal Incontinence 
 
 
Version 7.0 
Protocol Number IRB-18-004642 
24February2023 
CONFIDENTIAL  Page 68 of 72 total number of pages includes protocol pages and table of contents 
 
 
Device Labeling  
(provided under separate cover)