NCT02196519

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2013

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2013

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

July 17, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 22, 2014

Completed
Last Updated

July 22, 2014

Status Verified

July 1, 2014

Enrollment Period

5 months

First QC Date

July 17, 2014

Last Update Submit

July 18, 2014

Conditions

Stoma Reversal Procedure

Outcome Measures

Primary Outcomes (1)

  • Number of Adverse Events

    30 days

Study Arms (1)

Test

EXPERIMENTAL

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

Device: Sylys Surgical Sealant

Interventions

Sylys Surgical SealantDEVICE
Test

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • W Bemelman

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

    PRINCIPAL INVESTIGATOR

  • E Consten

    Meander Medical Center- Amersfoort

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 17, 2014

First Posted

July 22, 2014

Study Start

April 1, 2013

Primary Completion

September 1, 2013

Study Completion

September 1, 2013

Last Updated

July 22, 2014

Record last verified: 2014-07