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

Cohera Medical

Status

Terminated

Conditions

Colorectal and Ileorectal Anastomosis

Treatments

Device: Test- Treatment with Sylys Surgical Sealan

Study type

Interventional

Funder types

Industry

Identifiers

NCT02960139

PRO-106-0119

Details and patient eligibility

About

The Cohera Sylys® Surgical Sealant study is a pivotal, prospective, randomized, controlled, multicenter superiority clinical study comparing standard anastomosis closure technique (Control) to standard closure technique plus Sylys® Surgical Sealant (Test) during stapled colorectal and ileorectal anastomosis procedures.

Enrollment

61 patients

Sex

All

Ages

22+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Be at least 22 years of age
Be scheduled for a stapled colorectal or ileorectal anastomosis procedure with or without diverting stoma
Agree to return for all follow-up evaluations and procedures specified in the protocol
Understand and give informed consent

Exclusion criteria

Albumin < 3
ASA ≥ 4
Neutropenia ≤ 800
Pregnancy
The following conditions involving compromised immune system: AIDS (HIV positive not excluded), neutropenia
Known blood clotting disorder requiring treatment
Any condition known to effect wound healing, such as collagen vascular disease
Have known or suspected allergy or sensitivity to any test materials or reagents
Concurrent use of fibrin sealants or other anastomosis care devices
Surgery for emergency abdominal indications
Has undergone a colorectal anastomosis procedure in the previous two months
Has an emergent infection related to a previous colorectal anastomosis procedure
Is scheduled to undergo a Hartmann's procedure
Is scheduled to undergo trans-anal endoscopic microsurgery (TEM) Is participating in another medical device trial related to colorectal anastomosis