Clinical Evaluation of Cohera Sylys Surgical Sealant as an Adjunct to Standard Bowel Anastomosis Closure

NCT ID: NCT02196519

Last Updated: 2014-07-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-04-30
• Study Completion Date: 2013-09-30

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.

Conditions

Stoma Reversal Procedure

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Test

All test arm subjects received Sylys Surgical sealant around anastomotic junction after closure.

Group Type: EXPERIMENTAL

Sylys Surgical Sealant

Intervention Type: DEVICE

Interventions

Sylys Surgical Sealant

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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 Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cohera Medical, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

W Bemelman

Role: PRINCIPAL_INVESTIGATOR

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

E Consten

Role: PRINCIPAL_INVESTIGATOR

Meander Medical Center- Amersfoort

Other Identifiers

PRO-106-0028

Identifier Type: -

Identifier Source: org_study_id