What is REBUILD Bioabsorbable studying for laparotomy?

REBUILD Bioabsorbable is being studied to evaluate its safety and performance in closing the abdominal wall after open laparotomy surgery for cancer treatment. The research aims to understand how well the device distributes suture tension and maintains abdominal wall integrity over one year. This study is led by AbSolutions Med Inc.

Who may be eligible for this laparotomy clinical trial?

Adults aged 18 to 75 years scheduled for open, elective laparotomy surgery to treat cancer may be eligible. Participants must be able to provide written informed consent and comply with study visits. Patients with current surgical site infections or previous failed hernia repairs are excluded. Please review eligibility criteria for more details.

Is there any cost to participate in this laparotomy clinical trial?

Study-related care, including the investigational device and all trial visits, is provided at no cost. However, personal expenses such as travel costs may vary and are not guaranteed to be reimbursed.

Actively Recruiting

Phase Not Applicable

Age: 18Years - 75Years

All Genders

ID05041530

Study of REBUILD Bioabsorbable Device for Closing the Abdomen After Cancer Surgery via Laparotomy

Led by AbSolutions Med Inc. · Updated on 2022-12-27

Participants Needed

Research Sites

13 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the REBUILD Bioabsorbable device to assess its safety and performance in patients undergoing open, elective, intent-to-cure laparotomy procedures for cancer treatment. This prospective, non-randomized, multi-center study aims to generate descriptive data on how REBUILD distributes suture tension in abdominal wall closures in oncology patients. The study focuses on device-related adverse events and the integrity of the abdominal wall over one year. Participants will have their abdominal wall closed using the REBUILD Bioabsorbable device combined with a surgeons choice of suture during their standard oncologic laparotomy procedure. The study is single-arm, meaning all participants receive the same investigational device without comparison to other treatments. The devices performance will be monitored over a 12-month period after surgery. During the study, participants will be followed up to assess safety and effectiveness. The primary safety outcome is the occurrence of device-related adverse events within 12 months. The primary performance outcome is evaluated through clinical abdominal examinations and, if available, CT scans within 12 months to confirm the abdominal walls integrity. Participants are expected to comply with follow-up visits and study requirements for the full duration of the study.

CONDITIONS

Brief Title

Abdominal Wall Closure After Laparotomy in Oncologic Surgery

Who Can Participate

Age: 18Years - 75Years

All Genders

Eligibility Criteria

You may qualify if you...

Patient is 18-75 years of age
Patient is scheduled for oncologic, open, elective, intent-to-cure laparotomy
Patient is able to provide written informed consent
Patient is able and willing to comply with all study requirements

You will not qualify if you...

Patient is scheduled for a palliative procedure
Patient has had previous failed surgical repair of a ventral or incisional hernia
Patient has a current infection at the intended surgical site
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

Research Team

Daniel Jacobs, MD

Kathryn Kelley, BSN

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