Clinical trial NCT02841891: A Clinical Study Comparing Standard Anastomosis Closure Technique to Standard Closure Techniques Plus Sylys® Surgical Sealant
Official title: A Prospective, Randomized, Controlled, Multicenter Clinical Study Comparing Standard Anastomosis Closure Technique to Standard Closure Techniques Plus Sylys® Surgical Sealant
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Colorectal and Ileorectal Anastomosis
Colocolic and Ileocolic Anastomosis
Coloanal and Ileoanal Anastomosis
Lead sponsor: Cohera Medical, Inc.
Sponsor class: INDUSTRY
First posted: 2016-07-22
Enrollment: 58
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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)

Primary outcomes:
measure: Safety of Sylys® Surgical Sealant: Number of Anastomosis-Related Complications
timeFrame: 26 Weeks
Secondary outcomes:
measure: Sealant Application Evaluation Questionnaire
timeFrame: At time of device application (during surgery)
measure: Reduction in Anastomotic Leaks
timeFrame: 26 Weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Mobile
country: United States
facility: University of Southern Alabama
state: Alabama
city: Orange
country: United States
facility: University of California Irvine
state: California
city: Denver
country: United States
facility: University of Colorado Denver
state: Colorado
city: Jacksonville
country: United States
facility: Mayo Clinic Florida
state: Florida
city: Tampa
country: United States
facility: University of South Florida
state: Florida
city: New Orleans
country: United States
facility: Tulane
state: Louisiana
city: New Orleans
country: United States
facility: Ochsner Medical Center
state: Louisiana
city: Rochester
country: United States
facility: Mayo Clinic Rochester
state: Minnesota
city: Stony Brook
country: United States
facility: Stony Brook University Hospital
state: New York
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Dallas
country: United States
facility: Baylor Scott & White Research Institute
state: Texas
city: Houston
country: United States
facility: Houston Methodist
state: Texas
city: Ogden
country: United States
facility: Intermountain Healthcare
state: Utah
city: Salt Lake City
country: United States
facility: Univeristy of Utah
state: Utah
Study officials:
References: