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NOT YET RECRUITING
NCT05687942
NA

The REBUILD Trial: Closure of the Abdominal Wall

Sponsor: AbSolutions Med Inc.

View on ClinicalTrials.gov

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

Interventions

DEVICE

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