The REBUILD Trial: Closure of the Abdominal Wall

Surgical Incision Clinical Trial

Official title:

The REBUILD Trial: A Prospective, Multi-Center, Single Arm Study Using REBUILD for Abdominal Wall Closure

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05687942
• Other study ID #: CTP-0002
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 2023
• Est. completion date: June 2026

Study information

• Verified date: January 2023
• Source: AbSolutions Med Inc.
• Contact: Dan Jacobs, MD
• Phone: 650-303-6140
• Email: djacobs[@]absolutionsmed.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: June 2026
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Patient is 22-80 years of age

2. Patient is undergoing a midline laparotomy procedure

3. Patient is able to provide written informed consent

4. Patient is able and willing to comply with all study requirements

Exclusion Criteria:

1. Patient has BMI > 40

2. Patients with available imaging measuring abdominal wall thickness < 5.7 mm or > 16.5 mm

3. Patient is scheduled for a palliative procedure or has a life expectancy of less than 12-months

4. Patient has mesh at the site of deployment

5. Patient has an ostomy within the planned midline closure site (4 cm either side of midline)

6. Patient has a CDC wound classification of Class IV

7. Patient has devitalized tissue present at the intended surgical site

8. Patient has any co-morbid conditions determined by the investigator to place them at a high risk of complications (e.g., severe cardiovascular disease, congestive heart failure NYHA Class III or IV, end-stage renal failure, liver cirrhosis, connective tissue disorder, poorly managed diabetes)

9. Patient is on any medication that the investigator determines creates a high risk for complications (e.g., antithrombotic, steroid, IV chemotherapy, immunosuppressive agent)

10. Patient has history of radiation therapy targeting the abdominal wall

11. Patient is participating in a concurrent investigational medical device study

12. Patient is pregnant or planning on becoming pregnant during the study period

13. Patient has a history of psychological condition, drug, or alcohol misuse which may interfere with their ability to be compliant with post-operative visits

Related Conditions & MeSH terms

• Surgical Incision
• Surgical Wound

Intervention

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

Country	Name	City	State
Israel	Rambam Health Care Campus	Haifa

Sponsors (2)

Lead Sponsor	Collaborator
AbSolutions Med Inc.	Cogent Technologies Corporation

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Day 30 (+14/-7 days)
Primary	Serious device related adverse events	The primary safety endpoint is serious device-related adverse events through 1-month follow-up.	Day 30 (+14/-7 days)