- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04130555
Safety and Performance Evaluation of a Biological Matrix Used for Rectal Prolapse Repair by Ventral Rectopexy
Observational Prospective Study of a Non-cross-linked Porcine Acellular Dermal Matrix in Ventral Mesh Rectopexy
The general objective of the study is to confirm the medium/long-term safety and clinical performance of the CELLIS Rectopexy membrane used in rectal prolapse repair by ventral rectopexy and to identify emerging risks in comparison to the clinical data related to other types of fixation material.
The present study will be a prospective multicentric non-randomized and non-controlled trial involving 55 patients followed for 24 months. The study will be conducted in France in 3 investigational centres.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The study will be prospective, multicentric, single-arm, observational (non-interventional) to evaluate the safety and performance of CELLIS Rectopexy used in rectal prolapse repair by ventral rectopexy.
All evaluations will be performed and products used according to the usual practice, without additional or unusual diagnostic, treatment and monitoring procedure.
The study will be conducted in France in 3 investigational centres including 55 patients scheduled for the repair of rectal prolapse.
Each patient will participate in one assessment period including a screening visit, followed by the day of surgical procedure and a hospitalization period. Patients will return for ambulatory visits at Day 30 (+/- 7 days), Month 6 (+/- 2 weeks), Month 12 (+/- 2 weeks) and Month 24 (+/-2 weeks).
The surgical technique used to repair rectal prolapse will be either Laparoscopic Ventral Rectopexy (LVR) or a robotic assisted rectopexy with the use of the da Vinci Surgical System (Intuitive Surgical, Inc., Sunnyvale, CA).
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
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Clermont-Ferrand, France, 63 003
- Chu Estaing
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Nantes, France, 44 093
- CHU Nantes Hôtel Dieu
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Pessac, France, 33 604
- Hôpital Haut-Lévèque- CHU de Bordeaux
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patient aged ≥18 years,
- Patient with an indication of rectal prolapse repair by ventral rectopexy (external and internal rectal prolapse),
- Patient being informed of its participation to the study and of the follow-up visits, and having no objection to the clinical data collection and medical file access,
- Patient being informed of the porcine origin of the device in advance of the procedure.
Exclusion Criteria:
- Patient with known hypersensitivity to porcine materials,
- Patient with an existing infection not appropriately treated,
- Patient who are pregnant,
- Patient having refused to participate to the study,
- Patient refusing to come back to the follow-up visits.
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
CELLIS Rectopexy
Rectal prolapse repair by ventral rectopexy with the CELLIS Rectopexy matrix
|
Biological membrane used in Laparoscopic Ventral Rectopexy (LVR) or robotic assisted rectopexy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of adverse events including reoperation and removal of the mesh
Time Frame: From the surgical procedure through the entire 24-month follow-up period
|
Percentage
|
From the surgical procedure through the entire 24-month follow-up period
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Description of device deficiency: 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.
Time Frame: During the surgical procedure
|
Summarized and listed
|
During the surgical procedure
|
Rate of structural defect recurrence based on rectal examination with/without adjunctive investigations as clinically indicated
Time Frame: Throughout the study until end of the 24-month follow-up period
|
Percentage
|
Throughout the study until end of the 24-month follow-up period
|
Rate of structural defect recurrence requiring reoperation
Time Frame: Throughout the study until end of the 24-month follow-up period
|
Percentage
|
Throughout the study until end of the 24-month follow-up period
|
Symptoms evolution: presence or absence of symptoms (constipation, fecal incontinence, bloody and/or mucous rectal discharge (soiling), unsatisfactory sexual activity, pain)
Time Frame: At baseline and at 30-day, 6-month, 12-month and 24-month follow-up visits
|
Described at each visit and compared to baseline
|
At baseline and at 30-day, 6-month, 12-month and 24-month follow-up visits
|
Symptoms severity scored by a visual analog scale (0-10; 0 corresponding to no impact on life and 10 corresponding to extreme, incapacitating impact)
Time Frame: At baseline and at 30-day, 6-month, 12-month and 24-month follow-up visits
|
Described at each visit and compared to baseline
|
At baseline and at 30-day, 6-month, 12-month and 24-month follow-up visits
|
Rate of symptoms recurrence
Time Frame: Throughout the study until end of the 24-month follow-up period
|
Percentage
|
Throughout the study until end of the 24-month follow-up period
|
Severity of disease by the use of the Cleveland Clinic Incontinence Score (CCIS)
Time Frame: At baseline and at 30-day, 6-month, 12-month and 24-month follow-up visits
|
Change from screening of total score at each follow-up visit.
This scoring system cross-tabulates frequencies and different anal incontinence presentations (Gas/Liquid/Solid/Pad use/Need for lifestyle alterations) and sums the returned score to a total of 0-20 (where 0 = perfect continence and 20 = complete incontinence).
|
At baseline and at 30-day, 6-month, 12-month and 24-month follow-up visits
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Severity of disease by the use of the Obstructed Defecation Score (ODS)
Time Frame: At baseline and at 30-day, 6-month, 12-month and 24-month follow-up visits
|
Change from screening of total score at each follow-up visit.
The ODS score is the sum of all points, with a minimum of 0 point and a maximum possible of 31 points with higher scores meaning worse outcome.
|
At baseline and at 30-day, 6-month, 12-month and 24-month follow-up visits
|
Quality of life by the use of the Short Form (36) Health Survey (SF-36) questionnaire
Time Frame: At baseline and at 24-month
|
Change from screening of each domain score and total score at 24-month.
The SF-36 has eight scaled scores; the scores are weighted sums of the questions in each section.
Scores range from 0 - 100 with lower scores = more disability, and higher scores = less disability
|
At baseline and at 24-month
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Guillaume MEURETTE, MD, CHU Nantes, France
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- RPR_01_CIP
- 2019-A02024-53 (ID-RCB) (Other Identifier: ANSM)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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