Ignite Creation Date:
2024-05-06 @ 6:29 PM
Last Modification Date:
2024-10-26 @ 2:49 PM
Study NCT ID:
NCT05687942
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-01-20
First Post:
2023-01-08
Brief Title:
The REBUILD Trial Closure of the Abdominal Wall
Sponsor:
AbSolutions Med Inc
Organization:
AbSolutions Med Inc
Study Overview
Official Title:
The REBUILD Trial A Prospective Multi-Center Single Arm Study Using REBUILD for Abdominal Wall Closure
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed Description:
The REBUILD Trial Protocol CTP-0002 is an investigational medical device study designed to demonstrate the efficacy and safety of REBUILD for abdominal wall closure AWC The primary evaluation period will include the first 30 days of follow up After the 1-month endpoint evaluation period additional follow-up at 3 6 12 and 24-months for post-market analysis and publication will be conducted All adverse events will be collected and reported for the full duration of the study
Primary efficacy endpoint will be evaluated based on the measured distance between the rectus abdominis muscles RAMs by MRI at 1-month Day 30 14-7 days post-surgery Day 0
Primary safety endpoint will be evaluated based on reported serious device-related adverse events through 1-month Day 30 14-7 days of follow-up
Primary efficacy endpoint will be evaluated based on the measured distance between the rectus abdominis muscles RAMs by MRI at 1-month Day 30 14-7 days post-surgery Day 0
Primary safety endpoint will be evaluated based on reported serious device-related adverse events through 1-month Day 30 14-7 days of follow-up
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None