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Abdominal Wall Closure After Laparotomy in Oncologic Surgery — REBUILD  

Laparotomy Clinical Trial

Official title:
A Prospective, Multi-Center, Single Arm, Feasibility Study Using REBUILD Bioabsorbable™ for Closure of the Abdominal Wall After Oncologic Laparotomy

Clinical Trial Summary

The REBUILD Study is a first-in-human evaluation of the safety and performance of REBUILD Bioabsorbable.

Clinical Trial Description

REBUILD is an investigational medical device designed to be used with third-party suture to distribute suture tension in abdominal wall closures. In this study, REBUILD will be used in oncology patients undergoing an open, elective, intent-to-cure, laparotomy procedure. The study is a prospective, non-randomized, multi-center study designed to generate descriptive data about the use of REBUILD. The primary safety outcome is reported device-related adverse events. The primary performance outcome is the integrity of the abdominal wall over one year assessed by clinical examination of the abdomen. If available, CT studies performed within 12 months post-procedure will be used to confirm apposition of the medial border of the rectus muscles and integrity of the abdominal wall. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05041530
Study type Interventional
Source AbSolutions Med Inc.
Contact Daniel Jacobs, MD
Phone 650-303-6140
Email danj@absolutionsmed.com
Status Recruiting
Phase N/A
Start date June 17, 2022
Completion date June 2023
View Details
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