Completed

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

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What is being collected

Data Collection

Collected from today forward - Prospective
Who is being recruted

Digestive System Diseases+7

+ Fistula

+ Gastrointestinal Diseases

+17 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: April 2009
See protocol details

Summary

Principal SponsorCook Group Incorporated
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: April 1, 2009

Actual date on which the first participant was enrolled.

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.

Official TitleA Single-center Single Arm Prospective Study Evaluating the Surgisis Biodesign Anal Fistula Plug
NCT00703131
Principal SponsorCook Group Incorporated
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

35 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Cohort

These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Digestive System DiseasesFistulaGastrointestinal DiseasesIntestinal DiseasesIntestinal FistulaRectal DiseasesRectal FistulaPathological Conditions, Signs and SymptomsDigestive System FistulaPathological Conditions, Anatomical

Criteria

4 inclusion criteria required to participate
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
13 exclusion criteria prevent from participating
Crohn's Disease
Ulcerative Colitis
HIV Positive
Immune System Disorder
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

King Khalid University Hospital

Riyadh, Saudi ArabiaOpen King Khalid University Hospital in Google Maps
CompletedOne Study Center