Gore-BioA Fistula Plug to Treat Transsphincteric Fistulas | NCT01584752

Studies
Gore-BioA Fistula Plug to Treat Transsphincteric Fistulas

NCT01584752

Sponsor

Central Finland Hospital District

Status

Terminated

Last Update Posted

Jul 26, 2019Actual

Enrollment

60Actual

Phase

Not provided

Conditions

Anal Fistula
Fecal Incontinence
Surgery

Interventions

Gore-BioA Fistula Plug

Countries

Finland

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 2019

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Recruitment not satisfactory

Expanded Access Info

Start Date

Nov 2011

Primary Completion Date

Dec 2014Actual

Completion Date

Nov 2015Actual

First Submitted Date

Apr 24, 2012

First Submission Date that Met QC Criteria

Apr 24, 2012

First Posted Date

Apr 25, 2012Estimated

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 25, 2019

Last Update Posted Date

Jul 26, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

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

Description Module

Brief Summary

This is a prospective clinical study on the efficacy of Gore-BioA fistula plug in high transsphincteric fistulas. Follow-up time is six months

Detailed Description

Inclusion criteria for the study is a patient with ultrasound or MRI proven high transsphincteric perianal fistula. Patients with Crohns disease, immunosuppressive medication, anovaginal fistula, radiation therapy or chemotherapy are excluded. A Seton is placed in the fistula track for two months before the application of the plug. Patients are followed up for six months. Symptoms of fecal incontinence before and after intervention are monitored with the Cleveland clinic incontinence score.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

12 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Fistula patients		Gore-BioA Fistula Plug	Procedure: Gore-BioA Fistula Plug

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Gore-BioA Fistula Plug	Procedure	Gore-BioA Fistula Plug	Fistula patients

Measure	Description	Time Frame
Healing of the fistula		6 months

Measure	Description	Time Frame
Symptoms of fecal incontinence		6 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age 18-70 years, male or female
High cryptoglandular perianal fistula
Written approval for the study
Sufficient co-operation for the study
Localization of the fistula by ultrasound or MRI

Exclusion Criteria:

Crohns disease
Immunosuppressive treatment
Anovaginal fistula
Radiation therapy 6 months before study
Chemotherapy 6 months before study
Low- or intersphincteric fistula

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Inhabitants of Finland

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Matti V Kairaluoma, ph.D	Central Hospital, Jyväskylä, Finland	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Helsinki University Hospital		Helsinki			Finland
Central Hospital

Condition Browse Module

MeSH Terms

ID	Term
D012003	Rectal Fistula
D005242	Fecal Incontinence

Ancestor Terms

ID	Term
D007412	Intestinal Fistula
D016154	Digestive System Fistula
D004066	Digestive System Diseases
D007410	Intestinal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided