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

A Prospective, Randomized, Controlled, Multicenter Clinical Study Comparing Standard Anastomosis Closure Technique to Standard Closure Techniques Plus Sylys® Surgical Sealant

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.

Study Overview

• Status: Terminated
• Conditions: Colorectal and Ileorectal Anastomosis; Colocolic and Ileocolic Anastomosis; Coloanal and Ileoanal Anastomosis
• Intervention / Treatment: Device: Sylys® Surgical Sealant; Procedure: Stapled Anastomosis Colectomy Procedure

• Study Type: Interventional
• Enrollment (Actual): 58
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety of Sylys® Surgical Sealant: Number of Anastomosis-Related Complications	Number of subjects with anastomosis-related complications	26 Weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sealant Application Evaluation Questionnaire	Questionnaire documenting the ability to apply the sealant adequately to the anastomosis	At time of device application (during surgery)
Reduction in Anastomotic Leaks	Comparison of anastomotic leak rate across all subjects	26 Weeks

Collaborators and Investigators

• Sponsor: Cohera Medical, Inc.

Study record dates

Study Major Dates

• Study Start: July 1, 2016
• Primary Completion (Actual): August 13, 2018
• Study Completion (Actual): August 13, 2018

Study Registration Dates

• First Submitted: July 18, 2016
• First Submitted That Met QC Criteria: July 21, 2016
• First Posted (Estimate): July 22, 2016

Study Record Updates

• Last Update Posted (Actual): August 16, 2018
• Last Update Submitted That Met QC Criteria: August 14, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: PRO-106-0129

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes