Abdominal Wall Closure After Laparotomy in Oncologic Surgery

NCT05041530 | Unknown DMC FDA Device

• 1 other identifier: CTP-0001
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Laparotomy

Keywords

Laparotomy; Abdominal Wall Closure

Outcome Measures

Primary Outcomes (2)

• Adverse Events

  The number of device-related adverse events

  12 months

• Performance

  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

Study Arms (1)

REBUILD

EXPERIMENTAL

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

Interventions

REBUILD Bioabsorbable DEVICE

REBUILD is an investigational medical device designed to be used with third-party suture to distribute suture tension in abdominal wall closures.

REBUILD

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 may not qualify if:

• 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.

Sponsors & Collaborators

• AbSolutions Med Inc.: lead
• Cogent Technologies Corporation: collaborator

Study Sites (2)

Clinica Medellin

Medellín, Antioquia, 050025, Colombia

RECRUITING

Clinica Las Americas

Medellín, Colombia

RECRUITING

Related Publications (27)

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Related Links

• American Society of Anesthesiologists Physical Status Classification System

Study Officials

• Luis J Palacios Fuenmayor, MD

  Clinica Las Americas

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Daniel Jacobs, MD

CONTACT

650-303-6140; danj@absolutionsmed.com

Kathryn Kelley, BSN

CONTACT

925-350-5173; kkelley@absolutionsmed.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Prospective, multi-center, single-arm, feasibility study

Study Record Dates

• First Submitted: September 3, 2021
• First Posted: September 13, 2021
• Study Start: June 17, 2022
• Primary Completion: March 1, 2023
• Study Completion: June 1, 2023
• Last Updated: December 27, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

CO (2)