TerminatedNot Applicable

Gore-BioA Fistula Plug to Treat Transsphincteric Fistulas

Stopped: Recruitment not satisfactory

Finland60 participantsStarted 2011-11

Plain-language 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

Who can participate

Age range18 Years – 70 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Healing of the fistula

Timeframe: 6 months

Trial details

NCT IDNCT01584752

SponsorCentral Finland Hospital District

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2014-12

View on ClinicalTrials.gov More Anal Fistula trials