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The purpose of this study is to determine whether the use of the Renew Insert is effective, tolerable and safe in the treatment of accidental bowel leakage due to bowel incontinence.
Prospective, open label, single-arm, non-randomized, multi-center study designed to evaluate the efficacy, safety and tolerability of the Renew Insert in moderate-to-severe bowel incontinence patients: Minimum Wexner score of 12 AND at least weekly (score 3 or higher) leakage of solid and or liquid type stool.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Renew Insert | Device | The Renew Insert is indicated for the management of accidental bowel leakage due to bowel incontinence. The Renew Insert is designed for self-insertion to seal and help prevent the involuntary leakage of stool from the rectum. |
| Measure | Description | Time Frame |
|---|---|---|
| Co-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. | This co-primary effectiveness endpoint was 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) | Reduction in accidental bowel leakage from Baseline (Weeks 1-4) through Treatment period (Weeks 5-16). |
| Co-primary Effectiveness Endpoint: A Relative Percentage Change in Wexner Score (or Bowel Incontinence) Severity by Comparing Post-treatment Wexner Scores to Pre-treatment (End of Baseline Period) Wexner Scores. | The Wexner fecal incontinence scale takes into account five parameters that are scored on a scale from zero (absent) to four (daily) frequency of incontinence to gas, liquid, solid, use of pad, and quality of life. Full continence is a Wexner total of zero (0), whereas full incontinence is a Wexner total of 20. This co-primary effectiveness endpoint is the mean % reduction in Wexner score from the baseline period to the end of the treatment period, which was calculated according to the following equation: % reduction in Wexner = 100% (baseline period Wexner - end treatment period Wexner) / (baseline period Wexner). | Wexner score was calculated at the end of the Baseline period (Weeks 1-4) to the end of the 12-Week Treatment Period (week 16). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Steven D Wexner, MD | Cleveland Clinic Florida | Principal Investigator |
| Emily Lukacz, MD | University of California, San Diego, CA | Principal Investigator |
| Mark Segall, MD | The medical office of Mark Segall MD | Principal Investigator |
| Eric G Weiss, MD | Cleveland Clinic Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dr. Segall | Los Gatos | California | 95032 | United States | ||
| UCSD Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26252852 | Derived | Lukacz ES, Segall MM, Wexner SD. Evaluation of an Anal Insert Device for the Conservative Management of Fecal Incontinence. Dis Colon Rectum. 2015 Sep;58(9):892-8. doi: 10.1097/DCR.0000000000000427. |
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Renew Medical conducted a multi-center, prospective, open label, single-arm, non-randomized pivotal study designed to establish the safety, effectiveness, and tolerability of the Renew Insert in subjects with moderate-to severe bowel incontinence (defined as having a Wexner score greater than 12).
Three (3) clinical sites participated in the US pivotal trial, enrolling a total of ninety-seven subjects. The trial consisted of a 4-week baseline evaluation period, a 12-week treatment period and a 4-week return to baseline period. The study started in December 2009 and completed in December 2011.
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| ID | Title | Description |
|---|---|---|
| FG000 | Renew Insert for Management of Accidental Bowel Leakage | The Renew Insert is designed for self-insertion to seal and help prevent involuntary leakage of stool from the rectum. The Insert is designed for single use and consists of two components: a soft, easily deformable silicone insert and a flexible plastic fingertip applicator. After self insertion into the anal canal the Insert is expelled with voluntary bowel movement or if desired, manually removed by the user. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline Period - 4 Weeks |
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| Treatment Period - 12 Weeks |
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| Return to Baseline Period - 4 Weeks |
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| ID | Title | Description |
|---|---|---|
| BG000 | Renew Insert for Management of Accidental Bowel Leakage |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Co-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. | This co-primary effectiveness endpoint was 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) | Primary cohort for the effectiveness analyses was the Modified Intent-To-Treat cohort which included all subjects who completed at least one week of Insert use during the 12 week Treatment Period. | Posted | Median | Inter-Quartile Range | percentage change | Reduction in accidental bowel leakage from Baseline (Weeks 1-4) through Treatment period (Weeks 5-16). |
|
Adverse events were collected on all subjects who used a Renew Insert through the end of study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intent-to-treat (ITT) Cohort | Subjects who used the Renew Insert. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Pain | Gastrointestinal disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Victoria Mackinnon, Vice President, Regulatory, Clinical & Quality | Renew Medical, Inc. | 1-888-987-2929 | victoria@renew-medical.com |
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| ID | Term |
|---|---|
| D005242 | Fecal Incontinence |
| D003967 | Diarrhea |
| D005414 | Flatulence |
| D009085 | Mucopolysaccharidosis IV |
| ID | Term |
|---|---|
| D012002 | Rectal Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| San Diego |
| California |
| 92103-8897 |
| United States |
| Cleveland Clinic Florida | Weston | Florida | 33331 | United States |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Modified Intent-to-Treat cohort included all subjects who completed week one and up to week 12 during the 12-Week Treatment Period.
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|
|
| Primary | Co-primary Effectiveness Endpoint: A Relative Percentage Change in Wexner Score (or Bowel Incontinence) Severity by Comparing Post-treatment Wexner Scores to Pre-treatment (End of Baseline Period) Wexner Scores. | The Wexner fecal incontinence scale takes into account five parameters that are scored on a scale from zero (absent) to four (daily) frequency of incontinence to gas, liquid, solid, use of pad, and quality of life. Full continence is a Wexner total of zero (0), whereas full incontinence is a Wexner total of 20. This co-primary effectiveness endpoint is the mean % reduction in Wexner score from the baseline period to the end of the treatment period, which was calculated according to the following equation: % reduction in Wexner = 100% (baseline period Wexner - end treatment period Wexner) / (baseline period Wexner). | Primary cohort for the effectiveness analyses was the Modified Intent-To-Treat cohort which included all subjects who completed at least one week of Insert use during the 12 week Treatment Period. | Posted | Median | Inter-Quartile Range | Percentage change | Wexner score was calculated at the end of the Baseline period (Weeks 1-4) to the end of the 12-Week Treatment Period (week 16). |
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|
|
| 0 |
| 91 |
| 91 |
| 91 |
| Accidental Bowel Leakage | Gastrointestinal disorders |
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| Anorectal Bleeding | Gastrointestinal disorders |
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| Anorectal Irritation | Gastrointestinal disorders |
|
| Anorectal Pain | Gastrointestinal disorders |
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| Anorectal Soreness | Gastrointestinal disorders |
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| Anorectal Urge | Gastrointestinal disorders |
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| Diarrhea | Gastrointestinal disorders |
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| Discomfort | Gastrointestinal disorders |
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| Gas | Gastrointestinal disorders |
|
| Device Displacement | General disorders |
|
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| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009083 | Mucopolysaccharidoses |
| D002239 | Carbohydrate Metabolism, Inborn Errors |
| D008661 | Metabolism, Inborn Errors |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D016464 | Lysosomal Storage Diseases |
| D017520 | Mucinoses |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |