Status:
COMPLETED
Safety and Performance Evaluation of a Biological Matrix Used for Rectal Prolapse Repair by Ventral Rectopexy
Lead Sponsor:
Meccellis Biotech
Conditions:
Rectal Prolapse
Eligibility:
All Genders
18+ years
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 identi...
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 rectope...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 11 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 26 2023
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT04130555
Start Date
December 11 2019
End Date
October 26 2023
Last Update
October 27 2023
Active Locations (3)
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1
CHU Estaing
Clermont-Ferrand, France, 63 003
2
CHU Nantes Hôtel Dieu
Nantes, France, 44 093
3
Hôpital Haut-Lévèque- CHU de Bordeaux
Pessac, France, 33 604