The REBUILD Trial: Closure of the Abdominal Wall

NCT ID: NCT05687942

Last Updated: 2023-01-20

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-31
• Study Completion Date: 2026-06-30

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.

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.

Conditions

Surgical Incision

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

REBUILD

REBUILD is an investigational medical device (bioabsorbable anchor and deployment instruments) used with third party suture to close the abdominal wall. As the suture and Anchor absorb, abdominal wall forces gradually transfer to the organizing scar, one of the tenets of successful wound tensile strength acquisition. After full absorption, no permanent material remains that would otherwise alter normal anatomy, anisotropic properties, or compliance of the abdominal wall (Deeken, 2017).

Group Type: EXPERIMENTAL

REBUILD

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

REBUILD Bioabsorbable, The REBUILD System

Eligibility Criteria

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

• Minimum Eligible Age: 22 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cogent Technologies Corporation

UNKNOWN

Sponsor Role: collaborator

AbSolutions Med Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Rambam Health Care Campus

Haifa, , Israel

Countries

Israel

Central Contacts

Dan Jacobs, MD

Role: CONTACT

djacobs@absolutionsmed.com

650-303-6140

Kathryn Kelley, RN, BSN

Role: CONTACT

kkelley@absolutionsmed.com

925-360-5173

Facility Contacts

Haim Gilshtein, MD

Role: primary

h.gilshtein@rambam.health.gov.il

+050-206-2089

Ortal Bar On

Role: backup

O_Bar_On@rambam.health.gov.il

+972 50-206-1391

Other Identifiers

CTP-0002

Identifier Type: -

Identifier Source: org_study_id