Anal FistulaRADIOFISTNCT03131297
Multicenter Prospective Evaluation of Radiofrequency for Anal Fistulas
A study testing treatment by radiofrequency in people with Anal Fistula, run by F Care Systems NV at 4 sites in France.
Trial summary
Anal fistula treatment is associated with increasing risk of anal incontinence until 40% of cases. New and alternative treatments (glue, advancement flap, plug…) decrease this risk, but with fistula efficacy treatment in 40 to 60% of cases. Radiofrequency might destroy fistula tract without lesion of anal sphincter. 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?
- treatment by radiofrequency
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 4 sitesFrance
- Study dates
- 17 Apr 2017to 5 Oct 2022
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult Patient agreeing to participate in the study and signing the consent to participate
- Patients with an anal fistula previously drained, without diverticulum> 10 mm in MRI after drainage.
- For women of childbearing age, they must have a negative urine pregnancy test
Who cannot join
- Patient minor,
- Patients who are linguistically or psychologically unable to understand the information given and to give informed consent,
- Patient incapable, in the opinion of the investigator, to complete the self-questionnaires,
- Against-indication to radiofrequency treatment (infectious anal pathologies, anal fissures, residual staples of previous treatment Longo,
- Pregnant woman,
- Patient carrying a pacemaker,
Show all 9Show fewer
- Patients participating in another clinical study,
- Against indication to the realization of an MRI,
- Patient with a fistula with insufficient drainage, against indicating the removal of the stem (congestive fistula, oozing, with internal and / or external congestive orifices).
Trial locations and contacts
4 sites in 1 country.
France4 sites
Chu Nantes
Nantes
Clinique Blomet
Paris, 75015
CHU Pontchaillou
Rennes
Hopital Bagatelle
Talence
About this study
Anal fistula treatment is associated with increasing risk of anal incontinence until 40% of cases. New and alternative treatments (glue, advancement flap, plug…) decrease this risk, but with fistula efficacy treatment in 40 to 60% of cases. Radiofrequency might destroy fistula tract without lesion of anal sphincter.
Objective : Fistula healing rate and anal continence, 6 and 12 months after radiofrequency procedure.
Read more
Methods : Clinical and MRI evaluation before, 6 and 12 months after treatment. Patients : 50 patients with low, high, complex and Crohn disease fistula. An intermediate analysis is expected after the first 20 patients, to verify morbidity.
Evaluations :
- Fistula clinical healing 6 and 12 months after procedure
- Fistula MRI healing 12 months after procedure
- Anal continence before and after procedure
- Feasibility og radiofrequency procedure
- Morbidity
- Success and failure prognostics factors of this procedure
Read the detailed description
: Anal fistula treatment is associated with increasing risk of anal incontinence until 40% of cases. New and alternative treatments (glue, advancement flap, plug…) decrease this risk, but with fistula efficacy treatment in 40 to 60% of cases. Radiofrequency might destroy fistula tract without lesion of anal sphincter.
Objective : Fistula healing rate and anal continence, 6 and 12 months after radiofrequency procedure.
Methods : Clinical and MRI evaluation before, 6 and 12 months after treatment. Patients : 50 patients with low, high, complex and Crohn disease fistula. An intermediate analysis is expected after the first 20 patients, to verify morbidity.
Evaluations :
- Fistula clinical healing 6 and 12 months after procedure
- Fistula MRI healing 12 months after procedure
- Anal continence before and after procedure
- Feasibility og radiofrequency procedure
- Morbidity
- Success and failure prognostics factors of this procedure
Schedule :
- First inclusion march 2017
- Last inclusion march 2018
- Evaluations until march 2019.
- Conditions
- Anal Fistula
- Being tested
- treatment by radiofrequency
- Keywords
- anal fistulas, evaluation of radiofrequency
- Medical subject headings
- Rectal Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
treatment by radiofrequencyProcedure or surgery
Radiofrequency might destroy fistula tract without lesion of anal sphincter.
| Study group | Role | What they receive |
|---|---|---|
| Anal fistula treated by radiofrequency | Experimental | treatment by radiofrequency: patient with anal fistula treated by radiofrequency Receives: Procedure: treatment by radiofrequency |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical healing of an anal fistula
Clinical healing of an anal fistula, 6 months after radiofrequency treatment: A fistula is clinically healed if there is no drain, the external and internal openings are non-inflammatory, clogged, and without flow.
Measured: 6 month
Secondary outcomes (9)
Clinical healing of an anal fistula,
Clinical healing of an anal fistula, 12 months after radiofrequency treatment: A fistula is clinically healed if there is no drain, the external and internal openings are non-inflammatory, clogged, and without flow.
Measured: 12 months
evaluate anal continuation
evaluate anal continuation with SELF-EVALUATION QUESTIONNAIRE
Measured: 12 months
Assessment of Feasibility of anal fistula treatment by radiofrequency
Assessment of feasibility by measurement of anal fistula drying
Measured: day 0 at inclusion
Determination of the optimal settings
Evaluate the parameters of the probe (25 watts, 120 ° C, power 150 joules / 0,5 cm)
Measured: 12 months
Patient satisfaction
self-assessment questionnaire with numerical scales
Measured: 6 months
Patient satisfaction
self-assessment questionnaire with numerical scales
Measured: 12 months
the rate and nature of post-operative complications
Number of Participants With Abnormal Values in MRI and Adverse Events That Are Related to Treatment
Measured: 12 months
Evolution in MRI
If the MRI has eliminated an undrained pathway, a diverticulum greater than 10 mm, a hyper-intensity in T2 and after injection of Gadolinium.
Measured: 12 month
Prognostic factors
Evaluate the prognostic factors of good or bad response to this treatment: type of fistula, settings of the probe and the drying of the fistula
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2017
- Study start17 Apr 2017
- Primary completion5 Oct 2020
- Study completion5 Oct 2022
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- F Care Systems NV
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Laurent Abramowitz, MD, Principal investigator, Clinique Blomet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03131297
- Sponsor's protocol ID
- 17LAZ_RadioFist
- Acronym
- RADIOFIST
- Status last verified
- Feb 2024
- First submitted
- 6 Apr 2017
- Last updated
- 23 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Prospective Evaluation of Radiofrequency for Anal Fistulas
- ClinicalTrials.gov ID
- NCT03131297
- Acronym / sponsor ID
- RADIOFIST / 17LAZ_RadioFist
- Conditions
- Anal Fistula
- Keywords
- anal fistulas, evaluation of radiofrequency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- F Care Systems NVIndustry (pharma, biotech, devices)
- Study start
- 17 Apr 2017 (actual)
- Primary completion
- 5 Oct 2020 (actual)
- Study completion
- 5 Oct 2022 (actual)
- First posted
- 27 Apr 2017 (actual)
- 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.
Anal fistula treatment is associated with increasing risk of anal incontinence until 40% of cases. New and alternative treatments (glue, advancement flap, plug…) decrease this risk, but with fistula efficacy treatment in 40 to 60% of cases. Radiofrequency might destroy fistula tract without lesion of anal sphincter.
Objective : Fistula healing rate and anal continence, 6 and 12 months after radiofrequency procedure.
Methods : Clinical and MRI evaluation before, 6 and 12 months after treatment. Patients : 50 patients with low, high, complex and Crohn disease fistula. An intermediate analysis is expected after the first 20 patients, to verify morbidity.
Evaluations :
- Fistula clinical healing 6 and 12 months after procedure
- Fistula MRI healing 12 months after procedure
- Anal continence before and after procedure
- Feasibility og radiofrequency procedure
- Morbidity
- Success and failure prognostics factors of this procedure
Detailed description
: Anal fistula treatment is associated with increasing risk of anal incontinence until 40% of cases. New and alternative treatments (glue, advancement flap, plug…) decrease this risk, but with fistula efficacy treatment in 40 to 60% of cases. Radiofrequency might destroy fistula tract without lesion of anal sphincter.
Objective : Fistula healing rate and anal continence, 6 and 12 months after radiofrequency procedure.
Methods : Clinical and MRI evaluation before, 6 and 12 months after treatment. Patients : 50 patients with low, high, complex and Crohn disease fistula. An intermediate analysis is expected after the first 20 patients, to verify morbidity.
Evaluations :
- Fistula clinical healing 6 and 12 months after procedure
- Fistula MRI healing 12 months after procedure
- Anal continence before and after procedure
- Feasibility og radiofrequency procedure
- Morbidity
- Success and failure prognostics factors of this procedure
Schedule :
- First inclusion march 2017
- Last inclusion march 2018
- Evaluations until march 2019.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Anal fistula treated by radiofrequency | Experimental | Procedure: treatment by radiofrequencytreatment by radiofrequency: patient with anal fistula treated by radiofrequency |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult Patient agreeing to participate in the study and signing the consent to participate
- Patients with an anal fistula previously drained, without diverticulum> 10 mm in MRI after drainage.
- For women of childbearing age, they must have a negative urine pregnancy test
Key exclusion criteria (9 listed)
- Patient minor,
- Patients who are linguistically or psychologically unable to understand the information given and to give informed consent,
- Patient incapable, in the opinion of the investigator, to complete the self-questionnaires,
- Against-indication to radiofrequency treatment (infectious anal pathologies, anal fissures, residual staples of previous treatment Longo,
- Pregnant woman,
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 |
|---|---|---|
| treatment by radiofrequencyRadiofrequency might destroy fistula tract without lesion of anal sphincter. | Procedure or surgery | Anal fistula treated by radiofrequency |
Primary outcome
Clinical healing of an anal fistula
Time frame: 6 month
Clinical healing of an anal fistula, 6 months after radiofrequency treatment: A fistula is clinically healed if there is no drain, the external and internal openings are non-inflammatory, clogged, and without flow.
9 secondary outcomes
Clinical healing of an anal fistula,
Time frame: 12 months
evaluate anal continuation
Time frame: 12 months
Assessment of Feasibility of anal fistula treatment by radiofrequency
Time frame: day 0 at inclusion
Determination of the optimal settings
Time frame: 12 months
Patient satisfaction
Time frame: 6 months
Patient satisfaction
Time frame: 12 months
the rate and nature of post-operative complications
Time frame: 12 months
Evolution in MRI
Time frame: 12 month
Prognostic factors
Time frame: 12 month
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 23 Feb 2024.
- 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.
Laurent Abramowitz, MD principal investigator
Clinique Blomet
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing treatment by radiofrequency in people with Anal Fistula, run by F Care Systems NV at 4 sites in France.
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 3 inclusion and 9 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 23 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. 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?
Clinical healing of an anal fistula (time frame: 6 month). 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 23 Feb 2024.