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

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ClinicalTrials.gov Identifier: NCT00703131
Recruitment Status : Completed
First Posted : June 23, 2008
Last Update Posted : February 11, 2015
Sponsor:
Information provided by (Responsible Party):
Cook Group Incorporated

Brief Summary:
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 or disease Intervention/treatment
Anal Fistula Device: Anal Fistula Plug (SurgiSIS AFP)

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
Actual Enrollment : 35 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Single-center Single Arm Prospective Study Evaluating the Surgisis Biodesign Anal Fistula Plug
Study Start Date : April 2009
Actual Primary Completion Date : November 2014
Actual Study Completion Date : November 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fistulas
U.S. FDA Resources

Group/Cohort Intervention/treatment
1
Anal Fistula Plug
Device: Anal Fistula Plug (SurgiSIS AFP)
Anal Fistula Plug
Other Name: SurgiSIS Biodesign



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

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


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

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

Responsible Party: Cook Group Incorporated
ClinicalTrials.gov Identifier: NCT00703131     History of Changes
Other Study ID Numbers: 07-012
First Posted: June 23, 2008    Key Record Dates
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