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A Randomized Clinical Trial Comparing Surgisis AFP to Advancement Flap for the Repair of Anal Fistulas

NCT00545441 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 86

Last updated 2014-12-17

Study results available
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Summary

The purpose of this study is to determine whether the Surgisis anal fistula plug is just as effective in healing anal fistulas as compared to the advancement flap procedure.

Conditions

  • Anal Fistula

Interventions

DEVICE

Surgisis Biodesign Anal Fistula Plug (Surgisis® AFP)

Surgical placement of the Surgisis AFP is performed under general anesthesia.

DEVICE

Flap

Advancement flap surgery is performed; no anal fistula plug is placed

Sponsors & Collaborators

  • Cook Biotech Incorporated

    collaborator INDUSTRY

  • Cook Ireland, Ltd.

    collaborator INDUSTRY

  • Cook Group Incorporated

    lead INDUSTRY

Principal Investigators

  • Thilo Schwandner, MD · Justus-Liebig-Universitat Giessen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-06-30
Primary Completion
2013-04-30
Completion
2013-04-30

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00545441 on ClinicalTrials.gov