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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00703131
First Posted: June 23, 2008
Last Update Posted: February 11, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Cook Group Incorporated
  Purpose
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.

Condition Intervention
Anal Fistula Device: Anal Fistula Plug (SurgiSIS AFP)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Single-center Single Arm Prospective Study Evaluating the Surgisis Biodesign Anal Fistula Plug

Resource links provided by NLM:


Further study details as provided by Cook Group Incorporated:

Primary Outcome Measures:
  • Healing Success [ Time Frame: 12 months ]

Secondary Outcome Measures:
  • Change in Quality of Life Measures [ Time Frame: 3, 6, and 12 months ]

Enrollment: 35
Study Start Date: April 2009
Study Completion Date: November 2014
Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
Anal Fistula Plug
Device: Anal Fistula Plug (SurgiSIS AFP)
Anal Fistula Plug
Other Name: SurgiSIS Biodesign

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Residents of Saudi Arabia with chronic anal fistula
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00703131


Locations
Saudi Arabia
King Khalid University Hospital
Riyadh, Saudi Arabia, 11472
Sponsors and Collaborators
Cook Group Incorporated
Investigators
Principal Investigator: Ahmad Zubaidi, MD King Khalid University Hospital
  More Information

Responsible Party: Cook Group Incorporated
ClinicalTrials.gov Identifier: NCT00703131     History of Changes
Other Study ID Numbers: 07-012
First Submitted: June 20, 2008
First Posted: June 23, 2008
Last Update Posted: February 11, 2015
Last Verified: February 2015

Keywords provided by Cook Group Incorporated:
fistula
anal fistula

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