Abdominal Wall Closure After Laparotomy in Oncologic Surgery (REBUILD)

December 22, 2022 updated by: AbSolutions Med Inc.

A Prospective, Multi-Center, Single Arm, Feasibility Study Using REBUILD Bioabsorbable™ for Closure of the Abdominal Wall After Oncologic Laparotomy

The REBUILD Study is a first-in-human evaluation of the safety and performance of REBUILD Bioabsorbable.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

REBUILD is an investigational medical device designed to be used with third-party suture to distribute suture tension in abdominal wall closures. In this study, REBUILD will be used in oncology patients undergoing an open, elective, intent-to-cure, laparotomy procedure. The study is a prospective, non-randomized, multi-center study designed to generate descriptive data about the use of REBUILD. The primary safety outcome is reported device-related adverse events. The primary performance outcome is the integrity of the abdominal wall over one year assessed by clinical examination of the abdomen. If available, CT studies performed within 12 months post-procedure will be used to confirm apposition of the medial border of the rectus muscles and integrity of the abdominal wall.

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Colombia
      • Medellin, Colombia
        • Recruiting
        • Clínica Las Américas
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Gabriel J Rendon, MD
        • Sub-Investigator:
          • Claudia Ochoa, MD
        • Sub-Investigator:
          • Sandra Molina, MD
    • Antioquia
      • Medellín, Antioquia, Colombia, 050025

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Patient is 18-75 years of age
  2. Patient is scheduled for oncologic, open, elective, intent-to-cure laparotomy
  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 is scheduled for a palliative procedure
  2. Patient has had previous failed surgical repair of a ventral or incisional hernia
  3. Patient has a current infection at the intended surgical site
  4. Patient is participating in a concurrent investigational medical device study
  5. Patient is pregnant or planning on becoming pregnant during the study period
  6. Patient has a history of psychological condition, drug or alcohol misuse which may interfere with their ability to be compliant with post-operative visits.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: REBUILD
Subjects who meet the inclusion criteria and agree to participate in the study will be enrolled and undergo oncologic laparotomy per the standard of care. The abdominal wall will be closed with REBUILD Bioabsorbable and suture of the surgeon's choice.
Device: REBUILD Bioabsorbable
REBUILD is an investigational medical device designed to be used with third-party suture to distribute suture tension in abdominal wall closures.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse Events
Time Frame: 12 months
The number of device-related adverse events
12 months
Performance
Time Frame: 12 months
The number of subjects with abdominal wall integrity at 3-, 6-, and 12-months post-surgery. Abdominal wall integrity will be assessed via clinical examination of the abdomen to identify a fascial defect, bulge, reducible palpable mass, or discomfort with a cough impulse. Standard of care CT or MR imaging that is performed within 12 months of the surgery will be evaluated to confirm apposition of the medial border of the rectus abdominis muscles and integrity of the abdominal wall.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AbSolutions Med Inc.

Collaborators

Cogent Technologies Corporation

Investigators

  • Principal Investigator: Luis J Palacios Fuenmayor, MD, Clínica Las Américas

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 17, 2022

Primary Completion (Anticipated)

March 1, 2023

Study Completion (Anticipated)

June 1, 2023

Study Registration Dates

First Submitted

September 3, 2021

First Submitted That Met QC Criteria

September 3, 2021

First Posted (Actual)

September 13, 2021

Study Record Updates

Last Update Posted (Actual)

December 27, 2022

Last Update Submitted That Met QC Criteria

December 22, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CTP-0001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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