Clinical Evaluation of Cohera Sylys Surgical Sealant as a... | NCT02196519

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

NCT02196519

Sponsor

Cohera Medical, Inc.

Status

Completed

Last Update Posted

Jul 22, 2014Estimated

Enrollment

16Actual

Phase

Not Applicable

Conditions

Stoma Reversal Procedure

Interventions

Sylys Surgical Sealant

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2013

Primary Completion Date

Sep 2013Actual

Completion Date

Sep 2013Actual

First Submitted Date

Jul 17, 2014

First Submission Date that Met QC Criteria

Jul 18, 2014

First Posted Date

Jul 22, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 18, 2014

Last Update Posted Date

Jul 22, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

16Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Test	Experimental	All test arm subjects received Sylys Surgical sealant around anastomotic junction after closure.	Device: Sylys Surgical Sealant

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Sylys Surgical Sealant	Device		Test

Measure	Description	Time Frame
Number of Adverse Events		30 days

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
W Bemelman	Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)	Principal Investigator
E Consten	Meander Medical Center- Amersfoort	Principal Investigator

Locations

Not provided