Surgisis Anal Fistula Plug Study: An Experience in Saudi Arabia (SurgiSIS AFP)

February 10, 2015 updated by: Cook Group Incorporated

A Single-center Single Arm Prospective Study Evaluating the Surgisis Biodesign Anal Fistula Plug

The Surgisis Anal Fistula Plug study is a clinical trial conducted in Saudi Arabia to study the safety and effectiveness of the Surgisis AFP Plug in the treatment of chronic anal fistulas.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Up to 30 patients will be treated with the Surgisis Anal Fistula Plug using a standardized surgical procedure to plug their anal fistula. Patients will be followed periodically until their 12-month follow-up.

Study Type

Observational

Enrollment (Actual)

35

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Saudi Arabia
      • Riyadh, Saudi Arabia, 11472
        • King Khalid University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Residents of Saudi Arabia with chronic anal fistula

Description

Inclusion Criteria:

  • 18 years old or older
  • Primary, persistent, or recurrent fistula tract that is either transsphincteric, suprasphincteric, or extrasphincteric
  • Signed informed consent
  • Willing to return for follow-up visits

Exclusion Criteria:

  • Crohn's Disease
  • Ulcerative Colitis
  • HIV Positive
  • Immune System Disorder
  • Collagen Disorder
  • Tuberculosis
  • History of radiation to anorectal region
  • Allergies to pig tissue
  • Religious or cultural objection to use of pig tissue in this surgical application
  • J-pouch fistulas
  • Previous Surgisis AFP Plug placement in target fistula tract
  • Tracts with acute abscess, infection or inflammation
  • Superficial fistula tracts conventionally treated with fistulotomy/fistulectomy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
1
Anal Fistula Plug
Device: Anal Fistula Plug (SurgiSIS AFP)
Anal Fistula Plug
Other Names:
  • SurgiSIS Biodesign

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Healing Success
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in Quality of Life Measures
Time Frame: 3, 6, and 12 months
3, 6, and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cook Group Incorporated

Investigators

  • Principal Investigator: Ahmad Zubaidi, MD, King Khalid University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2009

Primary Completion (Actual)

November 1, 2014

Study Completion (Actual)

November 1, 2014

Study Registration Dates

First Submitted

June 20, 2008

First Submitted That Met QC Criteria

June 20, 2008

First Posted (Estimate)

June 23, 2008

Study Record Updates

Last Update Posted (Estimate)

February 11, 2015

Last Update Submitted That Met QC Criteria

February 10, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 07-012

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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