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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.

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

Condition or disease Intervention/treatment Phase
Laparotomy Device: REBUILD Bioabsorbable Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
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
Official Title: A Prospective, Multi-Center, Single Arm, Feasibility Study Using REBUILD Bioabsorbable™ for Closure of the Abdominal Wall After Oncologic Laparotomy
Actual Study Start Date : June 17, 2022
Estimated Primary Completion Date : March 2023
Estimated Study Completion Date : June 2023
Arms and Interventions
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Arm Intervention/treatment
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.
 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.


Outcome Measures
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Primary Outcome Measures :
  1. Adverse Events [ Time Frame: 12 months ]
    The number of device-related adverse events

  2. 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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05041530


Contacts
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Contact: Daniel Jacobs, MD 650-303-6140 danj@absolutionsmed.com
Contact: Kathryn Kelley, BSN 925-350-5173 kkelley@absolutionsmed.com

Locations
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Colombia
Clinica Medellin Recruiting
Medellín, Antioquia, Colombia, 050025
Contact: Gloria Salazar    574 444 61 52 ext 256    gloria.salazar@clinicamedellin.com   
Contact: Claudia Asela    3166224596    danacaya51@gmail.com   
Principal Investigator: Juan C Correa, M.D.         
Clinica Las Americas Recruiting
Medellin, Colombia
Contact: Luis J Palacios Fuenmayor, MD    57-310-737-9611    luis.palacios@lasamericas.com.co   
Contact: Laura Lobo    57-314-641-2839    laura.lobo@lasamericas.com.co   
Sub-Investigator: Gabriel J Rendon, MD         
Sub-Investigator: Claudia Ochoa, MD         
Sub-Investigator: Sandra Molina, MD         
Sponsors and Collaborators
AbSolutions Med Inc.
Cogent Technologies Corporation
Investigators
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Principal Investigator: Luis J Palacios Fuenmayor, MD Clinica Las Americas
More Information
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Additional Information:

Publications:

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Responsible Party: AbSolutions Med Inc.
ClinicalTrials.gov Identifier: NCT05041530    
Other Study ID Numbers: CTP-0001
First Posted: September 13, 2021    Key Record Dates
Last Update Posted: December 27, 2022
Last Verified: December 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by AbSolutions Med Inc.:
Laparotomy
Abdominal Wall Closure