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The REBUILD Trial: Closure of the Abdominal Wall
Sponsor: AbSolutions Med Inc.
Summary
The main objective of this clinical trial is to demonstrate the safety and efficacy of REBUILD when used to support abdominal wall closure after laparotomy. The main question it aims to answer are whether the device when used to support suture in abdominal wall closure safely maintains apposition of the abdominis rectus muscles within a pre-defined distance. Participants will undergo standard of care laparotomy and the investigational device will be used to support the suture used to close the abdominal wall. Participants will have an MRI at 1-month after surgery to measure the distance between the abdominus rectus muscles.
Official title: The REBUILD Trial: A Prospective, Multi-Center, Single Arm Study Using REBUILD for Abdominal Wall Closure
Key Details
Gender
All
Age Range
22 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
40
Start Date
2023-03
Completion Date
2026-06
Last Updated
2023-01-20
Healthy Volunteers
No
Conditions
Interventions
REBUILD
3.1.1. REBUILD is an investigational medical device provided as a sterile, single use set containing 10 suture Anchors and two non-implantable Carriers, with reusable stainless-steel instruments for deployment supplied separately.
Locations (1)
Rambam Health Care Campus
Haifa, Israel