Anal FistulaNCT01290666
Study of GORE® BIO-A® Fistula Plug for Use in Anal Fistula Repair
An observational study of Anal Fistula, run by W.L.Gore & Associates.
Trial summary
Primary outcome variable is healing at the final follow up visit. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anal Fistula
- What is being tested?
- Fistula Plug
- Type of treatment
- Medical device
- How many people
- 93 participants
- Where
- No sites listed yet
- Study dates
- Mar 2011to Sep 2014
- Phase
- Observational
- 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
Study population: All patients presenting with anal fistulae that meet inclusion and exclusion criteria.
Who may be able to join
- Transsphincteric fistula consisting of 1 tract(defined as a fistula which would not be amenable to fistulotomy); determined during operative procedure
- Likely cryptoglandular origin
- Must be at least 18 years of age
- Patients informed about the study, and will have read, understood and signed the patient informed consent and authorization to use PHI data, as applicable
- Patients willing and able to submit to postoperative follow-up evaluations
Who cannot join
- Crohn's Disease
- Evidence of on-going local infection
- History of more than 2 prior definitive repair attempts; repair attempt is defined as any of the following: advancement flap, cutting seton, fistulotomy, fistulectomy, fibrin glue, anal fistula plug, LIFT
- Superficial fistulas without any muscle involvement
- Fistulae of traumatic origin, including obstetric
- Intersphincteric fistulas that would be candidate for fistulotomy
Show all 14Show fewer
- Horseshoe or multi-tract fistulas
- Ano-vaginal or recto-vaginal fistulas
- Anastomotic fistulas (ileo-anal, colo-anal)
- A wound-healing or autoimmune disorder (including insulin-dependent diabetics)
- Subjects who are immunocompromised such as, with HIV, or currently receiving chemo or radiation therapy
- Subjects who are immunosuppressed, e.g. transplant patients, patients taking steroids, TNF agents, methotrexate
- History of prior or current pelvic radiation
- Difficulty comprehending or complying with the study (in surgeon's opinion)
About this study
Official title: Multicenter,Prospective, Observational Study of GORE® BIO-A® Fistula Plug for Use in Anal Fistula Repair
Primary outcome variable is healing at the final follow up visit.
Read the detailed description
The primary purpose of this prospective, multicenter, observational, single arm study is to further substantiate efficacy of the GORE® BIO-A® Fistula Plug when used as a soft tissue reinforcement of anal fistula repair and healing.
- Conditions
- Anal Fistula
- Being tested
- Fistula Plug
- Medical subject headings
- Rectal Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fistula PlugDevice
Also called GORE® BIO-A® Fistula Plug
Bioabsorbable fistula plug
| Study group | Role | What they receive |
|---|---|---|
| GORE® BIO-A® Fistula Plug | All patients in study receive the GORE® BIO-A® Fistula Plug. Receives: Device: Fistula Plug |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fistula Closure
Measured: 12 months post procedure
Secondary outcomes (1)
Duration of Drainage Post Procedure
Measured: Follow up out to 12 months post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2011 (estimated)
- Study startMar 2011
- Primary completionMay 2014
- Study completionSep 2014
Why it stopped: Sufficient patient population achieved; decision not due to product complaints.
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anal FistulaStudies of the same condition, open and under way.
- More trials run by W.L.Gore & AssociatesThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- W.L.Gore & Associates
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael J Stamos, MD, Principal investigator, University of California, Irvine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01290666
- Sponsor's protocol ID
- CS157
- Status last verified
- Nov 2016
- First submitted
- 3 Feb 2011
- Last updated
- 13 Jan 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Stamos MJ, Snyder M, Robb BW, Ky A, Singer M, Stewart DB, Sonoda T, Abcarian H. Prospective multicenter study of a synthetic bioabsorbable anal fistula plug to treat cryptoglandular transsphincteric anal fistulas. Dis Colon Rectum. 2015 Mar;58(3):344-51. doi: 10.1097/DCR.0000000000000288.
PubMed 25664714
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter,Prospective, Observational Study of GORE® BIO-A® Fistula Plug for Use in Anal Fistula Repair
- ClinicalTrials.gov ID
- NCT01290666
- Acronym / sponsor ID
- CS157
- Conditions
- Anal Fistula
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Sufficient patient population achieved; decision not due to product complaints.
- Enrolment
- 93 participants (actual)
- Lead sponsor
- W.L.Gore & AssociatesIndustry (pharma, biotech, devices)
- Study start
- Mar 2011
- Primary completion
- May 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 7 Feb 2011 (estimated)
- Results
- Posted 13 Jan 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Primary outcome variable is healing at the final follow up visit.
Detailed description
The primary purpose of this prospective, multicenter, observational, single arm study is to further substantiate efficacy of the GORE® BIO-A® Fistula Plug when used as a soft tissue reinforcement of anal fistula repair and healing.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GORE® BIO-A® Fistula Plug | – | Device: Fistula PlugAll patients in study receive the GORE® BIO-A® Fistula Plug. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients presenting with anal fistulae that meet inclusion and exclusion criteria.
Key inclusion criteria (5 listed)
- Transsphincteric fistula consisting of 1 tract(defined as a fistula which would not be amenable to fistulotomy); determined during operative procedure
- Likely cryptoglandular origin
- Must be at least 18 years of age
- Patients informed about the study, and will have read, understood and signed the patient informed consent and authorization to use PHI data, as applicable
- Patients willing and able to submit to postoperative follow-up evaluations
Key exclusion criteria (14 listed)
- Crohn's Disease
- Evidence of on-going local infection
- History of more than 2 prior definitive repair attempts; repair attempt is defined as any of the following: advancement flap, cutting seton, fistulotomy, fistulectomy, fibrin glue, anal fistula plug, LIFT
- Superficial fistulas without any muscle involvement
- Fistulae of traumatic origin, including obstetric
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 |
|---|---|---|
| Fistula PlugAlso: GORE® BIO-A® Fistula PlugBioabsorbable fistula plug | Device | GORE® BIO-A® Fistula Plug |
Primary outcome
Fistula Closure
Time frame: 12 months post procedure
1 secondary outcome
Duration of Drainage Post Procedure
Time frame: Follow up out to 12 months post procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 25664714Stamos MJ, Snyder M, Robb BW, Ky A, Singer M, Stewart DB, Sonoda T, Abcarian H. Prospective multicenter study of a synthetic bioabsorbable anal fistula plug to treat cryptoglandular transsphincteric anal fistulas. Dis Colon Rectum. 2015 Mar;58(3):344-51. doi: 10.1097/DCR.0000000000000288.
- Individual participant dataSharing planned: No
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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.
Michael J Stamos, MD principal investigator
University of California, Irvine
Questions about this trial
What is this clinical trial studying?
An observational study of Anal Fistula, run by W.L.Gore & Associates.
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 5 inclusion and 14 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 13 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
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 13 Jan 2017). 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 (time frame: 12 months post procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01290666, which also lists 1 linked publication.
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 13 Jan 2017.