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Trial record 1 of 1 for:    NCT05041530
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Abdominal Wall Closure After Laparotomy in Oncologic Surgery (REBUILD)

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ClinicalTrials.gov Identifier: NCT05041530
Recruitment Status : Recruiting
First Posted : September 13, 2021
Last Update Posted : December 27, 2022
Sponsor:
Collaborator:
Cogent Technologies Corporation
Information provided by (Responsible Party):
AbSolutions Med Inc.

Tracking Information
First Submitted Date  ICMJE September 3, 2021
First Posted Date  ICMJE September 13, 2021
Last Update Posted Date December 27, 2022
Actual Study Start Date  ICMJE June 17, 2022
Estimated Primary Completion Date March 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 15, 2022)
  • Adverse Events [ Time Frame: 12 months ]
    The number of device-related adverse events
  • 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.
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Abdominal Wall Closure After Laparotomy in Oncologic Surgery
Official Title  ICMJE A Prospective, Multi-Center, Single Arm, Feasibility Study Using REBUILD Bioabsorbable™ for Closure of the Abdominal Wall After Oncologic Laparotomy
Brief 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
Prospective, multi-center, single-arm, feasibility study
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Laparotomy
Intervention  ICMJE 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.
Study Arms  ICMJE 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.
Intervention: Device: REBUILD Bioabsorbable
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 15, 2022)		 30
Original Enrollment  ICMJE Not Provided
Estimated Study Completion Date  ICMJE June 2023
Estimated Primary Completion Date March 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Daniel Jacobs, MD 650-303-6140 danj@absolutionsmed.com
Contact: Kathryn Kelley, BSN 925-350-5173 kkelley@absolutionsmed.com
Listed Location Countries  ICMJE Colombia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05041530
Other Study ID Numbers  ICMJE CTP-0001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party AbSolutions Med Inc.
Original Responsible Party [Redacted]
Current Study Sponsor  ICMJE AbSolutions Med Inc.
Original Study Sponsor  ICMJE [Redacted]
Collaborators  ICMJE Cogent Technologies Corporation
Investigators  ICMJE
Principal Investigator: Luis J Palacios Fuenmayor, MD Clinica Las Americas
PRS Account AbSolutions Med Inc.
Verification Date December 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP