Anal FistulaSurgiSIS AFPNCT00703131
Surgisis Anal Fistula Plug Study: An Experience in Saudi Arabia
An observational study of Anal Fistula, run by Cook Group Incorporated at 1 site in Saudi Arabia.
Trial 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 more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Anal Fistula
- What is being tested?
- Anal Fistula Plug (SurgiSIS AFP)
- Type of treatment
- Medical device
- How many people
- 35 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- Apr 2009to Nov 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Residents of Saudi Arabia with chronic anal fistula
Who may be able to join
- 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
Who cannot join
- Crohn's Disease
- Ulcerative Colitis
- HIV Positive
- Immune System Disorder
- Collagen Disorder
- Tuberculosis
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-center Single Arm Prospective Study Evaluating the Surgisis Biodesign Anal Fistula Plug
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.
- Conditions
- Anal Fistula
- Being tested
- Anal Fistula Plug (SurgiSIS AFP)
- Keywords
- fistula, anal fistula
- Medical subject headings
- Rectal Fistula, Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anal Fistula Plug (SurgiSIS AFP)Device
Also called SurgiSIS Biodesign
Anal Fistula Plug
| Study group | Role | What they receive |
|---|---|---|
| 1 | Anal Fistula Plug Receives: Device: Anal Fistula Plug (SurgiSIS AFP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Healing Success
Measured: 12 months
Secondary outcomes (1)
Change in Quality of Life Measures
Measured: 3, 6, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2008 (estimated)
- Study startApr 2009
- Primary completionNov 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anal FistulaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cook Group Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ahmad Zubaidi, MD, Principal investigator, King Khalid University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00703131
- Sponsor's protocol ID
- 07-012
- Acronym
- SurgiSIS AFP
- Status last verified
- Feb 2015
- First submitted
- 20 Jun 2008
- Last updated
- 11 Feb 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center Single Arm Prospective Study Evaluating the Surgisis Biodesign Anal Fistula Plug
- ClinicalTrials.gov ID
- NCT00703131
- Acronym / sponsor ID
- SurgiSIS AFP / 07-012
- Conditions
- Anal Fistula
- Keywords
- fistula, anal fistula
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Cook Group IncorporatedIndustry (pharma, biotech, devices)
- Study start
- Apr 2009
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 23 Jun 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Device: Anal Fistula Plug (SurgiSIS AFP)Anal Fistula Plug |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Residents of Saudi Arabia with chronic anal fistula
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (13 listed)
- Crohn's Disease
- Ulcerative Colitis
- HIV Positive
- Immune System Disorder
- Collagen Disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anal Fistula Plug (SurgiSIS AFP)Also: SurgiSIS BiodesignAnal Fistula Plug | Device | 1 |
Primary outcome
Healing Success
Time frame: 12 months
1 secondary outcome
Change in Quality of Life Measures
Time frame: 3, 6, and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmad Zubaidi, MD principal investigator
King Khalid University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anal Fistula, run by Cook Group Incorporated at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Healing Success (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2015.