Safety and Performance Evaluation of a Biological Matrix Used for Rectal Prolapse Repair by Ventral Rectopexy
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.
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).
Study Design
Conditions
Rectal Prolapse
Intervention
CELLIS Rectopexy (Porcine Acellular Dermal Matrix, PADM)
Location
CHU Estaing
Clermont-Ferrand
France
63 003
Status
Not yet recruiting
Source
Meccellis Biotech
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT04130555
- ClinicalTrials.gov processed this data on October 22, 2019
Published on BioPortfolio: 2019-10-23T13:11:49-0400
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Medical and Biotech [MESH] Definitions
Bowman Membrane
A layer of acellular matrix that lies beneath the CORNEAL EPITHELIUM and above the CORNEAL STROMA. It consists of randomly arranged COLLAGEN fibers in a condensed bed of intercellular substance. It provides stability and strength to the cornea.
Enteroviruses, Porcine
Species of ENTEROVIRUS causing mild to severe neurological diseases among pigs especially in Eastern Europe. Mild strains are also present in Canada, U.S., and Australia. Specific species include Porcine enterovirus A and Porcine enterovirus B.
Diphtheria-tetanus-acellular Pertussis Vaccines
Combined vaccines consisting of DIPHTHERIA TOXOID; TETANUS TOXOID; and an acellular form of PERTUSSIS VACCINE. At least five different purified antigens of B. pertussis have been used in various combinations in these vaccines.
Matrix Metalloproteinase 20
A secreted matrix metalloproteinase that is the predominant proteolytic activity in the enamel matrix. The enzyme has a high specificity for dental enamel matrix protein AMELOGENIN.
Matrix Metalloproteinase 16
A transmembrane domain-containing matrix metalloproteinase. It is synthesized as an inactive zymogen that is activated by the proteolytic action of PROPROTEIN CONVERTASES. Matrix metalloproteinase 16 plays a direct role in the cleavage of proteins in the pericellular environment. In addition it can function indirectly by enzymatically activating the proprotein form of other MATRIX METALLOPROTEINASES such as the zymogen of MATRIX METALLOPROTEINASE 2.
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