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CompletedNCT00703131SurgiSIS AFPUpdated Feb 11, 2015

Surgisis Anal Fistula Plug Study: An Experience in Saudi Arabia

An observational study in Anal Fistula, sponsored by Cook Group Incorporated. Completed at 1 site in Saudi Arabia. Per ClinicalTrials.gov, last updated 2015-02-11.

Sponsored by Cook Group Incorporated · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
35
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Anal Fistula

Keywords

  • fistula
  • anal fistula
03

In context

Rectal Fistula

189 studies on the registry are indexed under Rectal Fistula; 42 are open to participants now.

This study's enrollment of 35 is below the median of 94 across 50 observational studies indexed under Rectal Fistula.

Browse Rectal Fistula studies →

Lead sponsor

Cook Group Incorporated is the lead sponsor of 73 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Residents of Saudi Arabia with chronic anal fistula

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

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
35 participants (actual)

Groups and cohorts

  • 1

    Anal Fistula Plug

    Device: Anal Fistula Plug (SurgiSIS AFP)

Interventions

  • DeviceAnal Fistula Plug (SurgiSIS AFP)

    Anal Fistula Plug

    Also known as: SurgiSIS Biodesign

06

What researchers measure

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

07

Study locations

1 site
  • King Khalid University Hospital
    Riyadh, 11472, Saudi Arabia
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 11, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00703131
Lead sponsor
Cook Group Incorporated
Responsible party
Sponsor
First posted
Jun 23, 2008
Start date
Apr 2009
Primary completion
Nov 2014
Completion
Nov 2014
Last update
Feb 11, 2015

Study contacts

Ahmad Zubaidi, MD
principal investigator · King Khalid University Hospital
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2015. You cannot join it, but the record below documents what was studied.

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