search
Back to results

The REBUILD Trial: Closure of the Abdominal Wall

Primary Purpose

Surgical Incision

Status
Not yet recruiting
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
REBUILD
Sponsored by
AbSolutions Med Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Surgical Incision focused on measuring abdominal wall closure, hernia, laparotomy, suture tension, REBUILD

Eligibility Criteria

22 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 Exclusion Criteria: 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 Patient has an ostomy within the planned midline closure site (4 cm either side of midline) Patient has a CDC wound classification of Class IV Patient has devitalized tissue present at the intended surgical site 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) Patient is on any medication that the investigator determines creates a high risk for complications (e.g., antithrombotic, steroid, IV chemotherapy, immunosuppressive agent) Patient has history of radiation therapy targeting the abdominal wall Patient is participating in a concurrent investigational medical device study Patient is pregnant or planning on becoming pregnant during the study period Patient has a history of psychological condition, drug, or alcohol misuse which may interfere with their ability to be compliant with post-operative visits

Sites / Locations

  • Rambam Health Care Campus

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

REBUILD

Arm Description

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).

Outcomes

Primary Outcome Measures

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).
Serious device related adverse events
The primary safety endpoint is serious device-related adverse events through 1-month follow-up.

Secondary Outcome Measures

Full Information

First Posted
January 8, 2023
Last Updated
January 18, 2023
Sponsor
AbSolutions Med Inc.
Collaborators
Cogent Technologies Corporation
search

1. Study Identification

Unique Protocol Identification Number
NCT05687942
Brief Title
The REBUILD Trial: Closure of the Abdominal Wall
Official Title
The REBUILD Trial: A Prospective, Multi-Center, Single Arm Study Using REBUILD for Abdominal Wall Closure
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
March 2023 (Anticipated)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
June 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AbSolutions Med Inc.
Collaborators
Cogent Technologies Corporation

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgical Incision
Keywords
abdominal wall closure, hernia, laparotomy, suture tension, REBUILD

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
REBUILD
Arm Type
Experimental
Arm Description
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).
Intervention Type
Device
Intervention Name(s)
REBUILD
Other Intervention Name(s)
REBUILD Bioabsorbable, The REBUILD System
Intervention Description
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.
Primary Outcome Measure Information:
Title
Efficacy Measure distance between the rectus abdominus muscles
Description
The primary efficacy endpoint is a maximum distance between the RAMs at 1-month after surgery < 2.5 cm (binary outcome).
Time Frame
Day 30 (+14/-7 days)
Title
Serious device related adverse events
Description
The primary safety endpoint is serious device-related adverse events through 1-month follow-up.
Time Frame
Day 30 (+14/-7 days)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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 Patient has an ostomy within the planned midline closure site (4 cm either side of midline) Patient has a CDC wound classification of Class IV Patient has devitalized tissue present at the intended surgical site 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) Patient is on any medication that the investigator determines creates a high risk for complications (e.g., antithrombotic, steroid, IV chemotherapy, immunosuppressive agent) Patient has history of radiation therapy targeting the abdominal wall Patient is participating in a concurrent investigational medical device study Patient is pregnant or planning on becoming pregnant during the study period Patient has a history of psychological condition, drug, or alcohol misuse which may interfere with their ability to be compliant with post-operative visits
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dan Jacobs, MD
Phone
650-303-6140
Email
djacobs@absolutionsmed.com
First Name & Middle Initial & Last Name or Official Title & Degree
Kathryn Kelley, RN, BSN
Phone
925-360-5173
Email
kkelley@absolutionsmed.com
Facility Information:
Facility Name
Rambam Health Care Campus
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Haim Gilshtein, MD
Phone
+050-206-2089
Email
h.gilshtein@rambam.health.gov.il
First Name & Middle Initial & Last Name & Degree
Ortal Bar On
Phone
+972 50-206-1391
Email
O_Bar_On@rambam.health.gov.il
First Name & Middle Initial & Last Name & Degree
Haim Gilshtein, MD
First Name & Middle Initial & Last Name & Degree
David Hochstein, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

The REBUILD Trial: Closure of the Abdominal Wall

We'll reach out to this number within 24 hrs