Anal FistulaNCT01584752
Gore-BioA Fistula Plug to Treat Transsphincteric Fistulas
An observational study of Anal Fistula and Fecal Incontinence, run by Central Finland Hospital District at 7 sites in Finland.
Trial summary
This is a prospective clinical study on the efficacy of Gore-BioA fistula plug in high transsphincteric fistulas. Follow-up time is six months Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Anal Fistula, Fecal Incontinence, Surgery
- What is being tested?
- Gore-BioA Fistula Plug
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 7 sitesFinland
- Study dates
- Nov 2011to Nov 2015
- How long will I take part?
- 12 Months
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Inhabitants of Finland
Who may be able to join
- Age 18-70 years, male or female
- High cryptoglandular perianal fistula
- Written approval for the study
- Sufficient co-operation for the study
- Localization of the fistula by ultrasound or MRI
Who cannot join
- Crohns disease
- Immunosuppressive treatment
- Anovaginal fistula
- Radiation therapy 6 months before study
- Chemotherapy 6 months before study
- Low- or intersphincteric fistula
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Finland7 sites
Helsinki University Hospital
Helsinki
Central Hospital
Joensuu
Central Hospital
Jyväskylä
Central Hospital
Lahti
Oulu University Hospital
Oulu
Central Hospital
Seinäjoki
Turku University Hospital
Turku
About this study
Official title: Clinical Multicenter Study of the Efficacy of Gore-BioA Fistula Plug in High Transsphincteric Perianal Fistulas
This is a prospective clinical study on the efficacy of Gore-BioA fistula plug in high transsphincteric fistulas. Follow-up time is six months
Read the detailed description
Inclusion criteria for the study is a patient with ultrasound or MRI proven high transsphincteric perianal fistula. Patients with Crohns disease, immunosuppressive medication, anovaginal fistula, radiation therapy or chemotherapy are excluded. A Seton is placed in the fistula track for two months before the application of the plug. Patients are followed up for six months. Symptoms of fecal incontinence before and after intervention are monitored with the Cleveland clinic incontinence score.
- Conditions
- Anal Fistula, Fecal Incontinence, Surgery
- Being tested
- Gore-BioA Fistula Plug
- Medical subject headings
- Rectal Fistula, Fecal Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gore-BioA Fistula PlugProcedure or surgery
Gore-BioA Fistula Plug
| Study group | Role | What they receive |
|---|---|---|
| Fistula patients | Gore-BioA Fistula Plug Receives: Procedure: Gore-BioA Fistula Plug |
What is being measured
The primary outcome is the main question the study is designed to answer.
Healing of the fistula
Measured: 6 months
Secondary outcomes (1)
Symptoms of fecal incontinence
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2012 (estimated)
- Study startNov 2011
- Primary completionDec 2014
- Study completionNov 2015
Why it stopped: Recruitment not satisfactory
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
- Case only
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Central Finland Hospital District
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Matti V Kairaluoma, ph.D, Study director, Central Hospital, Jyväskylä, Finland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01584752
- Sponsor's protocol ID
- KSSHP1U/2011
- Status last verified
- Jul 2019
- First submitted
- 24 Apr 2012
- Last updated
- 26 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Multicenter Study of the Efficacy of Gore-BioA Fistula Plug in High Transsphincteric Perianal Fistulas
- ClinicalTrials.gov ID
- NCT01584752
- Acronym / sponsor ID
- KSSHP1U/2011
- Conditions
- Anal Fistula, Fecal Incontinence, Surgery
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Recruitment not satisfactory
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Central Finland Hospital DistrictUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Dec 2014 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 25 Apr 2012 (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.
This is a prospective clinical study on the efficacy of Gore-BioA fistula plug in high transsphincteric fistulas. Follow-up time is six months
Detailed description
Inclusion criteria for the study is a patient with ultrasound or MRI proven high transsphincteric perianal fistula. Patients with Crohns disease, immunosuppressive medication, anovaginal fistula, radiation therapy or chemotherapy are excluded. A Seton is placed in the fistula track for two months before the application of the plug. Patients are followed up for six months. Symptoms of fecal incontinence before and after intervention are monitored with the Cleveland clinic incontinence score.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fistula patients | – | Procedure: Gore-BioA Fistula PlugGore-BioA Fistula Plug |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Inhabitants of Finland
Key inclusion criteria (5 listed)
- Age 18-70 years, male or female
- High cryptoglandular perianal fistula
- Written approval for the study
- Sufficient co-operation for the study
- Localization of the fistula by ultrasound or MRI
Key exclusion criteria (6 listed)
- Crohns disease
- Immunosuppressive treatment
- Anovaginal fistula
- Radiation therapy 6 months before study
- Chemotherapy 6 months before study
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 |
|---|---|---|
| Gore-BioA Fistula PlugGore-BioA Fistula Plug | Procedure or surgery | Fistula patients |
Primary outcome
Healing of the fistula
Time frame: 6 months
1 secondary outcome
Symptoms of fecal incontinence
Time frame: 6 months
Results and safety
The study was stopped early (reason given: Recruitment not satisfactory). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2019.
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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.
Matti V Kairaluoma, ph.D study director
Central Hospital, Jyväskylä, Finland
7 sites 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 and Fecal Incontinence, run by Central Finland Hospital District at 7 sites in Finland.
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 6 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 26 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Finland. 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 was stopped early (reason given: Recruitment not satisfactory). Results are not available in the source record.
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 of the fistula (time frame: 6 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 26 Jul 2019.