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

Colorectal and Ileorectal Anastomosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02841891
• Other study ID #: PRO-106-0129
• Status: Terminated
• Phase: N/A
• Start date: July 2016
• Est. completion date: August 13, 2018

Study information

• Verified date: August 2018
• Source: Cohera Medical, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 58
• Est. completion date: August 13, 2018
• Est. primary completion date: August 13, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Coloanal and Ileoanal Anastomosis
• Colocolic and Ileocolic Anastomosis
• Colorectal and Ileorectal Anastomosis

Intervention

Device:
• Sylys® Surgical Sealant
Standard Stapled Anastomosis Colectomy Procedure with the addition of Sylys® Surgical Sealant

Procedure:
• Stapled Anastomosis Colectomy Procedure
Standard Stapled Anastomosis Colectomy Procedure without the addition of Sylys® Surgical Sealant

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Baylor Scott & White Research Institute	Dallas	Texas
United States	University of Colorado Denver	Denver	Colorado
United States	Duke University	Durham	North Carolina
United States	Houston Methodist	Houston	Texas
United States	Mayo Clinic Florida	Jacksonville	Florida
United States	University of Southern Alabama	Mobile	Alabama
United States	Ochsner Medical Center	New Orleans	Louisiana
United States	Tulane	New Orleans	Louisiana
United States	Intermountain Healthcare	Ogden	Utah
United States	University of California Irvine	Orange	California
United States	Mayo Clinic Rochester	Rochester	Minnesota
United States	Univeristy of Utah	Salt Lake City	Utah
United States	Stony Brook University Hospital	Stony Brook	New York
United States	University of South Florida	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Cohera Medical, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety of Sylys® Surgical Sealant: Number of Anastomosis-Related Complications	Number of subjects with anastomosis-related complications	26 Weeks
Secondary	Sealant Application Evaluation Questionnaire	Questionnaire documenting the ability to apply the sealant adequately to the anastomosis	At time of device application (during surgery)
Secondary	Reduction in Anastomotic Leaks	Comparison of anastomotic leak rate across all subjects	26 Weeks