NCT00703131

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2009

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 20, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 23, 2008

Completed
9 months until next milestone

Study Start

First participant enrolled

April 1, 2009

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
Last Updated

February 11, 2015

Status Verified

February 1, 2015

Enrollment Period

5.6 years

First QC Date

June 20, 2008

Last Update Submit

February 10, 2015

Conditions

Anal Fistula

Keywords

fistulaanal fistula

Outcome Measures

Primary Outcomes (1)

  • Healing Success

    12 months

Secondary Outcomes (1)

  • Change in Quality of Life Measures

    3, 6, and 12 months

Study Arms (1)

1

Anal Fistula Plug

Device: Anal Fistula Plug (SurgiSIS AFP)

Interventions

Anal Fistula Plug (SurgiSIS AFP)DEVICE

Anal Fistula Plug

Also known as: SurgiSIS Biodesign
1

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Residents of Saudi Arabia with chronic anal fistula

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

King Khalid University Hospital

Riyadh, 11472, Saudi Arabia

Location

MeSH Terms

Conditions

Rectal FistulaFistula

Condition Hierarchy (Ancestors)

Intestinal FistulaDigestive System FistulaDigestive System DiseasesIntestinal DiseasesGastrointestinal DiseasesRectal DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Ahmad Zubaidi, MD

    King Khalid University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 20, 2008

First Posted

June 23, 2008

Study Start

April 1, 2009

Primary Completion

November 1, 2014

Study Completion

November 1, 2014

Last Updated

February 11, 2015

Record last verified: 2015-02

Locations

SA(1)