Abdominal Wall Closure After Laparotomy in Oncologic Surgery

Last updated: December 22, 2022
Sponsor: AbSolutions Med Inc.
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT05041530
CTP-0001
  • Ages 18-75
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

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

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 mayinterfere with their ability to be compliant with post-operative visits.

Study Design

Total Participants: 30
Study Start date:
June 17, 2022
Estimated Completion Date:
June 30, 2023

Study 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.

Connect with a study center

  • Clinica Medellin

    Medellín, Antioquia 050025
    Colombia

    Active - Recruiting

  • Hospital Universitario Fundacion Santa Fe de Bogota

    Bogotá,
    Colombia

    Site Not Available

  • Clinica Las Americas

    Medellin,
    Colombia

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.