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

Launched by MECCELLIS BIOTECH · Oct 15, 2019

Keywords

ClinConnect Summary

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 ...

Gender

ALL

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.