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

NCT04130555 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 55

Last updated 2023-10-27

No results posted yet for this study

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.

Conditions

  • Rectal Prolapse

Interventions

DEVICE

CELLIS Rectopexy (Porcine Acellular Dermal Matrix, PADM)

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

Sponsors & Collaborators

  • Meccellis Biotech

    lead INDUSTRY

Principal Investigators

  • Guillaume MEURETTE, MD · CHU Nantes, France

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-11
Primary Completion
2023-10-26
Completion
2023-10-26

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04130555 on ClinicalTrials.gov