Anal FistulaSurgiSIS AFPNCT00610207
Treatment of Crohn's Fistula Using a Porcine Intestine Submucosa Graft
A study testing Surgisis Biodesign Anal Fistula Plug (SurgiSIS AFP) in people with Anal Fistula and Crohn's Disease, run by Cook Group Incorporated at 3 sites in United States.
Trial summary
Healing anal fistulas in Crohn's patients with an anal fistula plug. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anal Fistula, Crohn's Disease
- What is being tested?
- Surgisis Biodesign Anal Fistula Plug (SurgiSIS AFP)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 3 sitesUnited States
- Study dates
- Mar 2007to Apr 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient is diagnosed with Crohn's Disease
- Patient has a chronically draining anal fistula of Crohn's origin
- Patient is 18 years old or older
- Patient has signed an informed consent
Who cannot join
- Patient is pregnant or lactating
- Patient has peri-anal drainage with originates from outside the anorectal tract
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Univeristy Hospitals Medical Center
Cleveland, Ohio, 44106
Cedars-Sinai Medical Center
Los Angeles, California, 90048
Mount Sinai Medical Center
New York, New York, 10029
About this study
Official title: Treatment of Crohn's Fistula Using a Porcine Intestine Submucosa Graft (SurgiSIS AFP)
Healing anal fistulas in Crohn's patients with an anal fistula plug.
Read the detailed description
The purpose of this study is to determine whether the Surgisis anal fistula plug is effective in healing anal fistulas in patients diagnosed with Crohn's Disease.
- Conditions
- Anal Fistula, Crohn's Disease
- Being tested
- Surgisis Biodesign Anal Fistula Plug (SurgiSIS AFP)
- Keywords
- Anal fistula, fistula in ano, anorectal fistula, Crohn's Disease
- Medical subject headings
- Rectal Fistula, Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgisis Biodesign Anal Fistula Plug (SurgiSIS AFP)Device
Also called SurgiSIS Biodesign
Surgical placement of the Surgisis AFP is performed under general anesthesia
| Study group | Role | What they receive |
|---|---|---|
| AFP | Experimental | Anal fistula plug placement performed during surgical procedure Receives: Device: Surgisis Biodesign Anal Fistula Plug (SurgiSIS AFP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fistula Closure (Patient Based)
Fistula closure is defined as absence of drainage at the external fistula opening.
Measured: 12 months
Fistula Closure (Tract Based)
Fistula closure is defined as absence of drainage at the external fistula opening.
An anorectal fistula is an inflammatory tract or connection between the epithelialized surface of the anal canal and most frequently, the perianal skin or perineum. It is possible to have multiple fistula tracts present on a patient.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2008 (estimated)
- Study startMar 2007
- Primary completionApr 2010
- Study completionApr 2010
Why it stopped: Study stopped early due to staffing changes at the site.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cook Group Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Cook Biotech Incorporated
- Responsible party
- Sponsor
- Investigators
- Beth Moore, MD, Principal investigator, Colon & Rectal Surgeons of Southern California, Mt. Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00610207
- Sponsor's protocol ID
- 06-002
- Acronym
- SurgiSIS AFP
- Status last verified
- Mar 2012
- First submitted
- 24 Jan 2008
- Last updated
- 2 Feb 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Crohn's Fistula Using a Porcine Intestine Submucosa Graft (SurgiSIS AFP)
- ClinicalTrials.gov ID
- NCT00610207
- Acronym / sponsor ID
- SurgiSIS AFP / 06-002
- Conditions
- Anal Fistula, Crohn's Disease
- Keywords
- Anal fistula, fistula in ano, anorectal fistula, Crohn's Disease
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study stopped early due to staffing changes at the site.
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Cook Group IncorporatedIndustry (pharma, biotech, devices)
- Collaborators
- Cook Biotech Incorporated
- Study start
- Mar 2007
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 7 Feb 2008 (estimated)
- Results
- Posted 17 Aug 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Healing anal fistulas in Crohn's patients with an anal fistula plug.
Detailed description
The purpose of this study is to determine whether the Surgisis anal fistula plug is effective in healing anal fistulas in patients diagnosed with Crohn's Disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AFP | Experimental | Device: Surgisis Biodesign Anal Fistula Plug (SurgiSIS AFP)Anal fistula plug placement performed during surgical procedure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient is diagnosed with Crohn's Disease
- Patient has a chronically draining anal fistula of Crohn's origin
- Patient is 18 years old or older
- Patient has signed an informed consent
Key exclusion criteria (2 listed)
- Patient is pregnant or lactating
- Patient has peri-anal drainage with originates from outside the anorectal tract
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 |
|---|---|---|
| Surgisis Biodesign Anal Fistula Plug (SurgiSIS AFP)Also: SurgiSIS BiodesignSurgical placement of the Surgisis AFP is performed under general anesthesia | Device | AFP |
Primary outcome
Fistula Closure (Patient Based)
Time frame: 12 months
Fistula closure is defined as absence of drainage at the external fistula opening.
Fistula Closure (Tract Based)
Time frame: 12 months
Fistula closure is defined as absence of drainage at the external fistula opening. An anorectal fistula is an inflammatory tract or connection between the epithelialized surface of the anal canal and most frequently, the perianal skin or perineum. It is possible to have multiple fistula tracts present on a patient.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Beth Moore, MD principal investigator
Colon & Rectal Surgeons of Southern California, Mt. Sinai
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surgisis Biodesign Anal Fistula Plug (SurgiSIS AFP) in people with Anal Fistula and Crohn's Disease, run by Cook Group Incorporated at 3 sites in United States.
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 2 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: stopped early, as of the sponsor's last update on 2 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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?
Yes. Results are posted in the registry (first posted 17 Aug 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Fistula Closure (Patient Based) (time frame: 12 months). The study lists 2 primary outcomes in all. 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 2 Feb 2016.