The REBUILD Trial: Closure of the Abdominal Wall
ConditionSurgical Incision
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age22-80
SponsorAbSolutions Med Inc.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patient is 22-80 years of age
Patient is undergoing a midline laparotomy procedure
Patient is able to provide written informed consent
Patient is able and willing to comply with all study requirements
Disqualifiers
Patient has BMI > 40
Patients with available imaging measuring abdominal wall thickness < 5.7 mm or > 16.5 mm
Patient is scheduled for a palliative procedure or has a life expectancy of less than 12-months
Patient has mesh at the site of deployment
Trial design
Design model
Single group
Treatments tested in this trial
REBUILD
Device3.1.1. 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.
Treatment groups
40 Participants
are divided into 1 treatment groupGroup A: REBUILDExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Efficacy Measure distance between the rectus abdominus muscles
The primary efficacy endpoint is a maximum distance between the RAMs at 1-month after surgery \< 2.5 cm (binary outcome).
Time frame
Day 30 (+14/-7 days)2
Serious device related adverse events
The primary safety endpoint is serious device-related adverse events through 1-month follow-up.
Time frame
Day 30 (+14/-7 days)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
AbSolutions Med Inc.
Lead sponsor
Cogent Technologies Corporation
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: