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Completed

NCT Number: NCT00703131

Surgisis Anal Fistula Plug Study: An Experience in Saudi Arabia

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.

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Key information

Conditions

Anal Fistula Digestive System Diseases Digestive System Fistula Fistula Gastrointestinal Diseases Intestinal Diseases Intestinal Fistula Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Rectal Diseases Rectal Fistula

Sex eligibility

All sexes

Study type

Observational

Primary location

King Khalid University Hospital

Riyadh, 11472, Saudi Arabia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Anal Fistula Plug (SurgiSIS AFP)

Device

Anal Fistula Plug

Other names: SurgiSIS Biodesign

Primary outcomes

  1. Healing Success

    Time frame: 12 months

Secondary outcomes

  1. Change in Quality of Life Measures

    Time frame: 3, 6, and 12 months

Sponsors and collaborators

Lead sponsor

Cook Group Incorporated

Industry

Registry information

Official study title

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

Acronym: SurgiSIS AFP

Important dates

Study start
2009
Primary completion
2014
Study completion
2014
First posted
Jun 23, 2008
Registry last updated
Feb 11, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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