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

NCT02196519 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2014-07-22

No results posted yet for this study

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

Interventions

DEVICE

Sylys Surgical Sealant

Sponsors & Collaborators

  • Cohera Medical, Inc.

    lead INDUSTRY

Principal Investigators

  • W Bemelman · Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

  • E Consten · Meander Medical Center- Amersfoort

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-04-30
Primary Completion
2013-09-30
Completion
2013-09-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02196519 on ClinicalTrials.gov