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A Clinical Study Comparing Standard Anastomosis Closure Technique to Standard Closure Techniques Plus Sylys® Surgical Sealant

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02841891
Recruitment Status : Terminated (Resource Constraints)
First Posted : July 22, 2016
Last Update Posted : August 16, 2018
Sponsor:
Information provided by (Responsible Party):
Cohera Medical, Inc.

Brief Summary:
The Cohera Sylys® Surgical Sealant study is a prospective, randomized, controlled, multicenter clinical study comparing standard anastomosis closure technique (Control) to standard closure technique plus Sylys® Surgical Sealant (Test) in patients undergoing a colectomy procedure with a stapled anastomosis.

Condition or disease Intervention/treatment Phase
Colorectal and Ileorectal Anastomosis Colocolic and Ileocolic Anastomosis Coloanal and Ileoanal Anastomosis Device: Sylys® Surgical Sealant Procedure: Stapled Anastomosis Colectomy Procedure Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 58 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Prospective, Randomized, Controlled, Multicenter Clinical Study Comparing Standard Anastomosis Closure Technique to Standard Closure Techniques Plus Sylys® Surgical Sealant
Study Start Date : July 2016
Actual Primary Completion Date : August 13, 2018
Actual Study Completion Date : August 13, 2018

Arm Intervention/treatment
Experimental: Test
Test group will receive Sylys® Surgical Sealant as an adjunct to standard closure of stapled anastomosis in colectomy procedure.
Device: Sylys® Surgical Sealant
Standard Stapled Anastomosis Colectomy Procedure with the addition of Sylys® Surgical Sealant

Active Comparator: Control
Control group will receive standard of care closure of stapled anastomosis in colectomy procedure without Sylys® Surgical Sealant.
Procedure: Stapled Anastomosis Colectomy Procedure
Standard Stapled Anastomosis Colectomy Procedure without the addition of Sylys® Surgical Sealant




Primary Outcome Measures :
  1. Safety of Sylys® Surgical Sealant: Number of Anastomosis-Related Complications [ Time Frame: 26 Weeks ]
    Number of subjects with anastomosis-related complications


Secondary Outcome Measures :
  1. Sealant Application Evaluation Questionnaire [ Time Frame: At time of device application (during surgery) ]
    Questionnaire documenting the ability to apply the sealant adequately to the anastomosis

  2. Reduction in Anastomotic Leaks [ Time Frame: 26 Weeks ]
    Comparison of anastomotic leak rate across all subjects



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   22 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Be 22 years of age or older
  • Be scheduled for a colectomy procedure with a stapled anastomosis
  • At time of surgery, has a completed anastomosis that is able to be visualized and is accessible to allow for circumferential sealant application with minimal bowel manipulation (≥90%)
  • Completed anastomosis must be at a location where a WCE can be performed to evaluate for a sub-clinical leak
  • Agree to return for all follow-up evaluations and procedures specified in the protocol
  • Understand and give informed consent

Exclusion Criteria:

  • Albumin < 3 g/dL
  • ASA score (American Society of Anesthesiologists) ≥ 4
  • Neutropenia ≤ 800 cells/µl
  • Pregnant at time of surgery
  • Has AIDS (HIV positive not excluded)
  • Has neutropenia (IBD and steroid use not excluded)
  • Has a known blood clotting disorder requiring treatment
  • Has any condition known to effect wound healing, such as collagen vascular disease
  • Has known or suspected allergy or sensitivity to any test materials, reagents, or WCE contrast materials
  • Has undergone chemotherapy within 4 weeks of the anastomosis procedure and/or radiation within 3 days of the anastomosis procedure
  • Concurrently using fibrin sealants or other anastomosis care devices
  • Emergency surgery for abdominal indications
  • Has undergone a colectomy procedure in the previous two months
  • Has an emergent infection related to a previous colectomy procedure
  • Is scheduled to undergo a Hartmann's procedure
  • Is scheduled to undergo trans-anal endoscopic microsurgery (TEM)
  • Is scheduled to undergo procedure using omental wrapping
  • Is participating in another medical device trial involving colectomy with anastomosis

First 20 subjects ONLY:

• Is diagnosed with high risk cancer as determined by preoperative clinical evidence or diagnostic imaging (if patient's cancer stage has been downstaged through treatment prior to baseline screening, subject is allowed to be included):

  • Lymph Node Cancer Stage: N2
  • Cancer Tumor Size: T4
  • Circumferential resection margin: CRM+ (Positive)

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): NCT02841891


Locations
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United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
University of Southern Alabama
Mobile, Alabama, United States, 36617
United States, California
University of California Irvine
Orange, California, United States, 92868
United States, Colorado
University of Colorado Denver
Denver, Colorado, United States, 80204
United States, Florida
Mayo Clinic Florida
Jacksonville, Florida, United States, 32224
University of South Florida
Tampa, Florida, United States, 33606
United States, Louisiana
Tulane
New Orleans, Louisiana, United States, 70112
Ochsner Medical Center
New Orleans, Louisiana, United States, 70121
United States, Minnesota
Mayo Clinic Rochester
Rochester, Minnesota, United States, 55905
United States, New York
Stony Brook University Hospital
Stony Brook, New York, United States, 11794
United States, North Carolina
Duke University
Durham, North Carolina, United States, 27710
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
United States, Texas
Baylor Scott & White Research Institute
Dallas, Texas, United States, 75246
Houston Methodist
Houston, Texas, United States, 77030
United States, Utah
Intermountain Healthcare
Ogden, Utah, United States, 84403
Univeristy of Utah
Salt Lake City, Utah, United States, 84132
Sponsors and Collaborators
Cohera Medical, Inc.

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Responsible Party: Cohera Medical, Inc.
ClinicalTrials.gov Identifier: NCT02841891     History of Changes
Other Study ID Numbers: PRO-106-0129
First Posted: July 22, 2016    Key Record Dates
Last Update Posted: August 16, 2018
Last Verified: August 2018

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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
Pediatric Postmarket Surveillance of a Device Product: No