Surgisis Anal Fistula Plug Study: An Experience in Saudi Arabia

NCT ID: NCT00703131

Last Updated: 2015-02-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

35 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-04-30

Study Completion Date

2014-11-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Anal Fistula

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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1

Anal Fistula Plug

Anal Fistula Plug (SurgiSIS AFP)

Intervention Type DEVICE

Anal Fistula Plug

Interventions

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Anal Fistula Plug (SurgiSIS AFP)

Anal Fistula Plug

Intervention Type DEVICE

Other Intervention Names

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SurgiSIS Biodesign

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cook Group Incorporated

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ahmad Zubaidi, MD

Role: PRINCIPAL_INVESTIGATOR

King Khalid University Hospital

Locations

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King Khalid University Hospital

Riyadh, , Saudi Arabia

Site Status

Countries

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Saudi Arabia

Other Identifiers

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07-012

Identifier Type: -

Identifier Source: org_study_id

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