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
Qualifiers
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
Treatments tested in this trial
- REBUILD
Treatment groups
40 Participants
are divided into 1 treatment groupSponsors and collaborators
AbSolutions Med Inc.
Lead sponsor
Cogent Technologies Corporation
Collaborator
Source ClinicalTrials.gov