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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Cook
ClinicalTrials.gov Identifier:
NCT00703131
First received: June 20, 2008
Last updated: July 29, 2014
Last verified: July 2014
  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:

Primary Outcome Measures:
  • Healing Success [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in Quality of Life Measures [ Time Frame: 3, 6, and 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: April 2009
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: October 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

Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00703131

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

No publications provided

Responsible Party: Cook
ClinicalTrials.gov Identifier: NCT00703131     History of Changes
Other Study ID Numbers: 07-012
Study First Received: June 20, 2008
Last Updated: July 29, 2014
Health Authority: Saudi Arabia: Ministry of Health

Keywords provided by Cook:
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

ClinicalTrials.gov processed this record on September 18, 2014