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

July 18, 2014 updated by: Cohera Medical, Inc.
A first in human study evaluating the safety of Sylys Surgical Sealant in protecting the anastomotic junction created during a stoma reversal procedure.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Test
All test arm subjects received Sylys Surgical sealant around anastomotic junction after closure.
Device: Sylys Surgical Sealant

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Adverse Events
Time Frame: 30 days
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cohera Medical, Inc.

Investigators

  • Principal Investigator: W Bemelman, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
  • Principal Investigator: E Consten, Meander Medical Center- Amersfoort

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (Actual)

September 1, 2013

Study Completion (Actual)

September 1, 2013

Study Registration Dates

First Submitted

July 17, 2014

First Submitted That Met QC Criteria

July 18, 2014

First Posted (Estimate)

July 22, 2014

Study Record Updates

Last Update Posted (Estimate)

July 22, 2014

Last Update Submitted That Met QC Criteria

July 18, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Other Study ID Numbers

  • PRO-106-0028

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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