NCT05041530

Abdominal Wall Closure After Laparotomy in Oncologic Surgery

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: AbSolutions Med Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Laparotomy

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-06-17
• Primary completion: 2023-03-01
• Completion: 2023-06-01
• First posted: 2021-09-13
• Last updated: 2022-12-27

Locations

2 sites across 1 country: Colombia

Regulatory

• FDA-regulated device study