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

Stopped early · Not applicable

Conditions studied: Colorectal and Ileorectal Anastomosis, Colocolic and Ileocolic Anastomosis, Coloanal and Ileoanal Anastomosis

In brief

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.

Key facts

Study ID

NCT02841891

Run by

Cohera Medical, Inc.

People needed

58

Starts

2016-07-01

Expected to finish

2018-08-13

Last updated by the study team

2018-08-16

Who can join

Age: 22 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• University of Southern Alabama — Mobile, 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
• University of South Florida — Tampa, 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
• Duke University — Durham, North Carolina, 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
• Intermountain Healthcare — Ogden, Utah, United States
• Univeristy of Utah — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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