Safety and Performance Evaluation of a Biological Matrix Used for Rectal Prolapse Repair by Ventral Rectopexy
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|ClinicalTrials.gov Identifier: NCT04130555|
Recruitment Status : Not yet recruiting
First Posted : October 17, 2019
Last Update Posted : October 21, 2019
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.
|Condition or disease||Intervention/treatment|
|Rectal Prolapse||Device: CELLIS Rectopexy (Porcine Acellular Dermal Matrix, PADM)|
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 :||Observational|
|Estimated Enrollment :||55 participants|
|Official Title:||Observational Prospective Study of a Non-cross-linked Porcine Acellular Dermal Matrix in Ventral Mesh Rectopexy|
|Estimated Study Start Date :||November 2019|
|Estimated Primary Completion Date :||November 2022|
|Estimated Study Completion Date :||November 2022|
Rectal prolapse repair by ventral rectopexy with the CELLIS Rectopexy matrix
Device: CELLIS Rectopexy (Porcine Acellular Dermal Matrix, PADM)
Biological membrane used in Laparoscopic Ventral Rectopexy (LVR) or robotic assisted rectopexy
- 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
- 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
- Rate of structural defect recurrence requiring reoperation [ Time Frame: Throughout the study until end of the 24-month follow-up period ]Percentage
- 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
- 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
- Rate of symptoms recurrence [ Time Frame: Throughout the study until end of the 24-month follow-up period ]Percentage
- 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).
- 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.
- 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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04130555
|Contact: Claire CISTERNI, PhD||+33 (0)6 68 13 76 firstname.lastname@example.org|
|Contact: Guillaume HOFMANSKI||+33 (0)7 61 31 11 email@example.com|
|Clermont-Ferrand, France, 63 003|
|Contact: Brigitte GILLET +33 (0)4 73 75 05 32 firstname.lastname@example.org|
|Principal Investigator: Anne DUBOIS, MD|
|CHU Nantes Hôtel Dieu|
|Nantes, France, 44 093|
|Contact: Vincent WYART +33 (0)2 40 08 49 66 Vincent.WYART@chu-nantes.fr|
|Principal Investigator: Guillaume MEURETTE, MD|
|Hôpital Haut-Lévèque- CHU de Bordeaux|
|Pessac, France, 33 604|
|Contact: Stéphanie GUILLON +33 (0)5 56 79 58 10 email@example.com|
|Principal Investigator: Eric RULLIER, MD|
|Principal Investigator:||Guillaume MEURETTE, MD||CHU Nantes, France|