Clinical Trial Details

Overview

Research Study Summary

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

Purpose

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.

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CW ID: 226362
Date Last Changed: September 8, 2017

Clinical Trial Snapshot

Gender
Both Male and Female
Age
22 and up
Overall Status
Recruiting
Lead Sponsor
Cohera Medical, Inc.
Facility Type
N/A

Eligibility

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:
  • 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):
  • Lymph Node Cancer Stage: N2
  • Cancer Tumor Size: T4
  • Circumferential resection margin: CRM+ (Positive)

More Info

PRO-106-0129

Contact

Rachel Karlnoski
University of South Florida - Tampa General Hospital
1 Tampa General Circle
Tampa, FL 33606
Phone: (813) 844-4133

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