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Gore-BioA Fistula Plug to Treat Transsphincteric Fistulas

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Central Finland Hospital District
ClinicalTrials.gov Identifier:
NCT01584752
First received: April 24, 2012
Last updated: November 21, 2014
Last verified: April 2012
  Purpose

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


Condition Intervention Phase
Anal Fistula
Fecal Incontinence
Surgery
Procedure: Gore-BioA Fistula Plug
Phase 3

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Official Title: Clinical Multicenter Study of the Efficacy of Gore-BioA Fistula Plug in High Transsphincteric Perianal Fistulas

Resource links provided by NLM:


Further study details as provided by Central Finland Hospital District:

Primary Outcome Measures:
  • Healing of the fistula [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Symptoms of fecal incontinence [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 60
Study Start Date: November 2011
Estimated Study Completion Date: November 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Fistula patients
Gore-BioA Fistula Plug
Procedure: Gore-BioA Fistula Plug
Gore-BioA Fistula Plug
Other Name: Gore-BioA Fistula Plug

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Inhabitants of Finland

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01584752

Locations
Finland
Helsinki University Hospital
Helsinki, Finland
Central Hospital
Joensuu, Finland
Central Hospital
Jyväskylä, Finland
Central Hospital
Lahti, Finland
Oulu University Hospital
Oulu, Finland
Central Hospital
Seinäjoki, Finland
Turku University Hospital
Turku, Finland
Sponsors and Collaborators
Central Finland Hospital District
Investigators
Study Director: Matti V Kairaluoma, ph.D Central Hospital, Jyväskylä, Finland
  More Information

No publications provided

Responsible Party: Central Finland Hospital District
ClinicalTrials.gov Identifier: NCT01584752     History of Changes
Other Study ID Numbers: KSSHP1U/2011
Study First Received: April 24, 2012
Last Updated: November 21, 2014
Health Authority: Finland: National Advisory Board on Health Care Ethics

Additional relevant MeSH terms:
Fecal Incontinence
Fistula
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Pathological Conditions, Anatomical
Rectal Diseases

ClinicalTrials.gov processed this record on November 25, 2014