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

Overview

About this study

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

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Be at least 22 years of age
  • Be scheduled for a colorectal or ileorectal anastomosis procedure with a diverting stoma
  • Agree to return for all follow-up evaluations and procedures specified in the protocol Understand and give informed consent

Exclusion Criteria:

A potential subject who meets any of the following criteria will be excluded from participation in this study;

  • Albumin < 3 g/dL
  • ASA score (American Society of Anesthesiologists) ≥ 4
  • Neutropenia ≤ 800 cells/µl
  • Pregnancy
  • The following conditions involving compromised immune system: AIDS (HIV positive not excluded), neutropenia
  • Known blood clotting disorder requiring treatment
  • 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
  • Patients who have undergone prior colorectal anastomosis surgery in the previous two months, or are receiving an additional anastomosis related to complications from a previous anastomosis procedure
  • Stage 1 (First 20 patients) Only (High Risk Cancer Patients (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)

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status

Jacksonville, Fla.

Mayo Clinic principal investigator

David Larson, M.D., M.B.A.

Closed for enrollment

Rochester, Minn.

Mayo Clinic principal investigator

David Larson, M.D., M.B.A.

Closed for enrollment

More information

Publications

Publications are currently not available

Additional contact information

Non-cancer trials contact form

Phone: 800-664-4542 (toll-free)

International patient clinical studies questions