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

Meccellis Biotech

Status: Completed

Conditions: Rectal Prolapse

Treatments: Device: CELLIS Rectopexy (Porcine Acellular Dermal Matrix, PADM)

Study type: Observational

Funder types: Industry

Identifiers

NCT04130555

2019-A02024-53 (ID-RCB) (Other Identifier)

RPR_01_CIP

Details and patient eligibility

About

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.

Full 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).

Enrollment: 55 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

55 participants in 1 patient group

CELLIS Rectopexy

Description:

Rectal prolapse repair by ventral rectopexy with the CELLIS Rectopexy matrix

Treatment:

Device: CELLIS Rectopexy (Porcine Acellular Dermal Matrix, PADM)