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Trial record 1 of 1 for:    NCT05687942
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The REBUILD Trial: Closure of the Abdominal Wall

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT05687942
Recruitment Status : Not yet recruiting
First Posted : January 18, 2023
Last Update Posted : January 20, 2023
Cogent Technologies Corporation
Information provided by (Responsible Party):
AbSolutions Med Inc.

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.

Condition or disease Intervention/treatment Phase
Surgical Incision Device: REBUILD Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: The scientific rationale for a single-arm study is based on existing data and experience associated with current approaches for managing abdominal closure. Suture techniques and mesh have been extensively studied (Deerenberg EB, 2015) (Jairam, 2017) and several clinical publications serve as historical precedents for the 1-month endpoint (Table 2). The results of this REBUILD Study will thus exist in a broad context of outcomes, allowing significant comparisons in the absence of a concomitant control group.
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: The REBUILD Trial: A Prospective, Multi-Center, Single Arm Study Using REBUILD for Abdominal Wall Closure
Estimated Study Start Date : March 2023
Estimated Primary Completion Date : September 2024
Estimated Study Completion Date : June 2026

Arm Intervention/treatment
Experimental: 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).
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.
Other Name: REBUILD Bioabsorbable, The REBUILD System

Primary Outcome Measures :
  1. Efficacy Measure distance between the rectus abdominus muscles [ Time Frame: Day 30 (+14/-7 days) ]
    The primary efficacy endpoint is a maximum distance between the RAMs at 1-month after surgery < 2.5 cm (binary outcome).

  2. Serious device related adverse events [ Time Frame: Day 30 (+14/-7 days) ]
    The primary safety endpoint is serious device-related adverse events through 1-month follow-up.

Information from the National Library of Medicine

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Ages Eligible for Study:   22 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT05687942

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Contact: Dan Jacobs, MD 650-303-6140
Contact: Kathryn Kelley, RN, BSN 925-360-5173

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Rambam Health Care Campus
Haifa, Israel, 3109601
Contact: Haim Gilshtein, MD    +050-206-2089   
Contact: Ortal Bar On    +972 50-206-1391   
Principal Investigator: Haim Gilshtein, MD         
Sub-Investigator: David Hochstein, MD         
Sponsors and Collaborators
AbSolutions Med Inc.
Cogent Technologies Corporation
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Responsible Party: AbSolutions Med Inc. Identifier: NCT05687942    
Other Study ID Numbers: CTP-0002
First Posted: January 18, 2023    Key Record Dates
Last Update Posted: January 20, 2023
Last Verified: January 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by AbSolutions Med Inc.:
abdominal wall closure
suture tension
Additional relevant MeSH terms:
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Surgical Wound
Wounds and Injuries