Status:
COMPLETED
Clinical Evaluation of Cohera Sylys Surgical Sealant as an Adjunct to Standard Bowel Anastomosis Closure
Lead Sponsor:
Cohera Medical, Inc.
Conditions:
Stoma Reversal Procedure
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
A first in human study evaluating the safety of Sylys Surgical Sealant in protecting the anastomotic junction created during a stoma reversal procedure.
Eligibility Criteria
Inclusion
- Be at least 18 years of age
- Be in good general health in the opinion of the investigator with no conditions that would significantly impact wound healing as determined by medical history and review of recent concomitant medications
- Be scheduled for an ileostomy reversal procedure
- Be willing to follow instructions for incision care
- Agree to return for all follow-up evaluations specified in this protocol
- Sign informed consent
Exclusion
- Anesthesia risk judged to be higher than ASA2
- Have severe co-morbid conditions that pose a high risk for surgery and adequate recovery (e.g., heart disease)
- Any condition involving compromised immune system
- Any condition known to effect wound healing, such as collagen vascular disease
- Known blood clotting disorder
- Be receiving antibiotic therapy for pre-existing condition or infection
- Concurrent use of fibrin sealants or other anastomosis care devices
- Be currently taking systemic steroids or immunosuppressive agents
- Have known or suspected allergy or sensitivity to any test materials or reagents
- Be participating in any current clinical trial or have participated in any clinical trial within 30 days of enrollment in this study
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2013
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT02196519
Start Date
April 1 2013
End Date
September 1 2013
Last Update
July 22 2014
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