Safety and Performance Evaluation of a Biological Matrix Used for Rectal Prolapse Repair by Ventral Rectopexy

NCT ID: NCT04130555

Last Updated: 2023-10-27

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 55 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-12-11
• Study Completion Date: 2023-10-26

Brief Summary

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.

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).

Conditions

Rectal Prolapse

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

CELLIS Rectopexy

Rectal prolapse repair by ventral rectopexy with the CELLIS Rectopexy matrix

CELLIS Rectopexy (Porcine Acellular Dermal Matrix, PADM)

Intervention Type: DEVICE

Biological membrane used in Laparoscopic Ventral Rectopexy (LVR) or robotic assisted rectopexy

Interventions

CELLIS Rectopexy (Porcine Acellular Dermal Matrix, PADM)

Biological membrane used in Laparoscopic Ventral Rectopexy (LVR) or robotic assisted rectopexy

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Meccellis Biotech

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Guillaume MEURETTE, MD

Role: PRINCIPAL_INVESTIGATOR

CHU Nantes, France

Locations

CHU Estaing

Clermont-Ferrand, , France

CHU Nantes Hôtel Dieu

Nantes, , France

Hôpital Haut-Lévèque- CHU de Bordeaux

Pessac, , France

Countries

France

Other Identifiers

2019-A02024-53 (ID-RCB)

Identifier Type: OTHER

Identifier Source: secondary_id

RPR_01_CIP

Identifier Type: -

Identifier Source: org_study_id