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

Not Applicable

Terminated

• Conditions: Colocolic and Ileocolic Anastomosis; Colorectal and Ileorectal Anastomosis; Coloanal and Ileoanal Anastomosis
• Interventions: Procedure: Stapled Anastomosis Colectomy Procedure; Device: Sylys® Surgical Sealant

• Registration Number: NCT02841891
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-07
• Study First Submitted: 2016-07-18
• Study First Submitted QC: 2016-07-21
• Study First Posted: 2016-07-22
• Status Verified: 2018-08
• Primary Completion: 2018-08-13
• Study Completion: 2018-08-13
• Last Update Submitted: 2018-08-14
• Last Update Posted: 2018-08-16

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 58

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Stapled Anastomosis Colectomy Procedure	Control group will receive standard of care closure of stapled anastomosis in colectomy procedure without Sylys® Surgical Sealant.
Test	Sylys® Surgical Sealant	Test group will receive Sylys® Surgical Sealant as an adjunct to standard closure of stapled anastomosis in colectomy procedure.

Primary Outcome Measures

Name	Time	Method
Safety of Sylys® Surgical Sealant: Number of Anastomosis-Related Complications	26 Weeks	Number of subjects with anastomosis-related complications

Secondary Outcome Measures

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

Trial Locations

Locations (16)

University of Southern Alabama; 🇺🇸 Mobile, Alabama, United States

Intermountain Healthcare; 🇺🇸 Ogden, Utah, United States

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States

University of California Irvine; 🇺🇸 Orange, California, United States

University of Colorado Denver; 🇺🇸 Denver, Colorado, United States

Mayo Clinic Florida; 🇺🇸 Jacksonville, Florida, United States

Tulane; 🇺🇸 New Orleans, Louisiana, United States

Ochsner Medical Center; 🇺🇸 New Orleans, Louisiana, United States

Mayo Clinic Rochester; 🇺🇸 Rochester, Minnesota, United States

Stony Brook University Hospital; 🇺🇸 Stony Brook, New York, United States

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States

Baylor Scott & White Research Institute; 🇺🇸 Dallas, Texas, United States

Houston Methodist; 🇺🇸 Houston, Texas, United States

Univeristy of Utah; 🇺🇸 Salt Lake City, Utah, United States

Duke University; 🇺🇸 Durham, North Carolina, United States

University of South Florida; 🇺🇸 Tampa, Florida, United States