Clinical Trials Logo
  1. Home
  2. Abdominal Wall Defect
  3. NCT04580511

Safety and Clinical Performance of a Biological Matrix Used in Abdominal Wall Reconstruction — PMCF_AWR  

Abdominal Wall Defect Clinical Trial

Official title:
Safety and Clinical Performance of a Non-cross-linked Porcine Acellular Dermal Matrix Used in Abdominal Wall Reconstruction: an Observational Prospective Study.

Clinical Trial Summary

The general objective of the study is to confirm the medium/long-term safety and clinical performance of the CELLIS membrane used in abdominal wall reconstruction including, but not limited to, ventral hernia repair and stoma closure, 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 noncontrolled trial involving 112 patients followed for 24 months. The study will be conducted in France in 3 investigational centres.

Clinical Trial Description

The study will be prospective, multicentric, single-arm, observational (non-interventional) to evaluate the safety and performance of the CELLIS membrane used in abdominal wall reconstruction including, but not limited to, ventral hernia repair and stoma closure. 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 112 patients scheduled for an abdominal wall reconstruction. Each patient will participate in one assessment period including a preoperative visit, followed by the day of surgical procedure and a hospitalization period. Patients will return for ambulatory visits on day 30 (+/- 7 days), on month 3 (+/- 2 weeks), on month 12 (+/- 2 weeks) and on month 24 (+/-2 weeks) post-surgery. CELLIS will be implanted by open technique following standard techniques. The membrane can be used in bridged or reinforced repairs. Mesh placement can include inlay (bridging), underlay intraperitoneal, sublay (retrorectus/retromuscular) positions. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04580511
Study type Observational
Source Meccellis Biotech
Contact Claire CISTERNI, PhD
Phone +33 (0)6 68 13 76 26
Email claire.cisterni@meccellis.com
Status Recruiting
Phase
Start date November 4, 2020
Completion date November 2026
View Details
See also
  Status Clinical Trial Phase
Completed NCT04644965 - Evaluation of the Motor Activity, Cardiopulmonary Performance Capacity and Quality of Life in Patients Born With a Congenital Abdominal Wall Defect
Recruiting NCT06086444 - Tranexamic Acid in Abdominoplasty. Phase 4
Recruiting NCT05579652 - Change in Fascial Tension in Open Abdomens
Terminated NCT03241719 - Novel Strategies to Improve Immunomodulation and Non-invasive Clinical Monitoring in VCA Early Phase 1
Recruiting NCT03765060 - The Efficacy and Security of the Small Stitch Technique in Emergency Surgery N/A
Recruiting NCT03035617 - Study to Evaluate Reduction in Pain After Laparoscopic Hernia Repair With Mesh Soaked in Bupivacaine Solution N/A
Completed NCT05061264 - Abdominal Wall Reconstruction With PVDF Mesh in the Setting of Active Infection N/A
Not yet recruiting NCT06364306 - oPen Versus RobotIc retrOmuscular Repair in Medium to Large Ventral Hernias N/A
Recruiting NCT03310905 - Abdominal Wall Transplant N/A
Completed NCT03960320 - Health Related Quality of Life of Patients With Abdominal Wall Defects
Recruiting NCT05308771 - To Investigate the Use of a New Syringe "Visual Pressure Control (VPC)" for Epidural Anesthesia in Children Surgery N/A
Recruiting NCT02416674 - Vascularized Composite Allotransplantation for Treatment of Abdominal Wall Defects Early Phase 1
Completed NCT05278117 - A Prospective Multicentre Study Evaluating the Outcomes of the Abdominal Wall Dehiscence Repair Using Posterior Component Separation With Transversus Abdominis Muscle Release Reinforced by a Retro-muscular Mesh - Filling a Step N/A
Completed NCT04947202 - Clinical Study on the Safety of SAFIL® MESH
Enrolling by invitation NCT03296475 - Intraoperative Biomechanics in Complex Abdominal Wall Reconstruction N/A
Completed NCT03702153 - The Use of Synthetic Mesh in Contaminated and Infected Abdominal Wall Repairs. A Long-term Prospective Clinical Trial N/A
Completed NCT05205213 - Stepwise for the Treatment of Lateral Incisional Hernias
Not yet recruiting NCT06367309 - ExtrAperitoneaL Plasty vs Intraperitoneal oNlay mEsh in Ventral Hernia Repair N/A