Anal FistulaNCT03690934
Treatment of Transsphicteric Fistula-in-ano by Method of Laser Thermoobliteration(FiLaC™).
A study testing Fistula-tract laser closure (FiLAC™) and Monopolar coagulation of fistulous tract in people with Anal Fistula, run by State Scientific Centre of Coloproctology, Russian Federation at 1 site in Russia.
Trial summary
This is a randomized, controlled, parallel study to compare the results of treatment for patients with transsphincteric fistulas-in-ano. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Anal Fistula
- What is being tested?
- Fistula-tract laser closure (FiLAC™) and Monopolar coagulation of fistulous tract
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteRussia
- Study dates
- 23 Oct 2017to 31 Aug 2020
- 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 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Informed consent to the study;
- Patients with high transsphincteric fistula (>1/3), suprasphincteric fistula whithout abscesses;
- The presence of a formed fistulous tract > 2 cm in length.
Who cannot join
- Suprasphincteric fistula with abscesses or infiltrates;
- Extrasphincteric fistula;
- Length of fistula tract < 2 cm;
- The presence of sever scars in the region of internal fistula opening, wide fistula opening > 5 mm;
- Crohn's fistulae
Trial locations and contacts
1 site in 1 country.
Russia1 site, 1 recruiting
- Recruiting
State Scientific Centre of Coloproctology
Moscow, 123423
Ivan Kostarev, MD
About this study
Official title: Randomized Conrtolled Study: Fistula Laser Closure (FiLaC™) vs Monopolar Coagulation for Treatment of Complex Anal Fistulae.
This is a randomized, controlled, parallel study to compare the results of treatment for patients with transsphincteric fistulas-in-ano.
Read the detailed description
We are planning to eroll 120 patients in this study,the duration of the stady be 3 years. Each of two groups will include 60 people. Pationts in the first group will be assigned to get treatment of the fistula-in-ano by laser thermo-obliteration (FiLAC™), patietns of the second group will forego monopolar coagulation of the fistulas tract with suturing the internal fistulas opening.
- Conditions
- Anal Fistula
- Being tested
- Fistula-tract laser closure (FiLAC™), Monopolar coagulation of fistulous tract
- 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-tract laser closure (FiLAC™)Procedure or surgery
The procedure was performed with a diode laser platform emitting laser energy of 15 W at a wavelength of 1470 nm by means of a radial fiber. For obliteration, the fistula track is treated with a continuous slow retraction of the laser fibre withdrawn at a rate of approximately 1 cm per 2-3s.
Monopolar coagulation of fistulous tractProcedure or surgery
The procedure was performed with a monopolar coagulator platform emitting monopolar coagulation. For obliteration, the fistula track is treated with a continuous slow retraction of the monopolar energy with suturing the internal fistulas opening.
| Study group | Role | What they receive |
|---|---|---|
| Fistula-tract laser closure (FiLAC™) | Experimental | The treatment technique consists of laser coagulation of fistulous tract walls with a diode laser with a wavelength of 1470 nm, which leads to thermo-obliteration of the fistulous tract. Receives: Procedure: Fistula-tract laser closure (FiLAC™) |
| Fistula monopolar cogulation | Active comparator | The treatment technicque consists of monopolar coagulation of fistulous tract walls with suturing the internal fistulas opening. Receives: Procedure: Monopolar coagulation of fistulous tract |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of healing
healing
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2018
- Study start23 Oct 2017
- Primary completion31 Aug 2020 (estimated)
- Study completion31 Aug 2020 (estimated)
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Assignment
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- State Scientific Centre of Coloproctology, Russian Federation
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03690934
- Sponsor's protocol ID
- 74
- Status last verified
- Oct 2018
- First submitted
- 12 Sep 2018
- Last updated
- 14 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Conrtolled Study: Fistula Laser Closure (FiLaC™) vs Monopolar Coagulation for Treatment of Complex Anal Fistulae.
- ClinicalTrials.gov ID
- NCT03690934
- Acronym / sponsor ID
- 74
- Conditions
- Anal Fistula
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- State Scientific Centre of Coloproctology, Russian FederationOther government
- Study start
- 23 Oct 2017 (actual)
- Primary completion
- 31 Aug 2020 (estimated)
- Study completion
- 31 Aug 2020 (estimated)
- First posted
- 1 Oct 2018 (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.
This is a randomized, controlled, parallel study to compare the results of treatment for patients with transsphincteric fistulas-in-ano.
Detailed description
We are planning to eroll 120 patients in this study,the duration of the stady be 3 years. Each of two groups will include 60 people. Pationts in the first group will be assigned to get treatment of the fistula-in-ano by laser thermo-obliteration (FiLAC™), patietns of the second group will forego monopolar coagulation of the fistulas tract with suturing the internal fistulas opening.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Assignment
| Arm | Type | Receives |
|---|---|---|
| Fistula-tract laser closure (FiLAC™) | Experimental | Procedure: Fistula-tract laser closure (FiLAC™)The treatment technique consists of laser coagulation of fistulous tract walls with a diode laser with a wavelength of 1470 nm, which leads to thermo-obliteration of the fistulous tract. |
| Fistula monopolar cogulation | Active comparator | Procedure: Monopolar coagulation of fistulous tractThe treatment technicque consists of monopolar coagulation of fistulous tract walls with suturing the internal fistulas opening. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Informed consent to the study;
- Patients with high transsphincteric fistula (>1/3), suprasphincteric fistula whithout abscesses;
- The presence of a formed fistulous tract > 2 cm in length.
Key exclusion criteria (5 listed)
- Suprasphincteric fistula with abscesses or infiltrates;
- Extrasphincteric fistula;
- Length of fistula tract < 2 cm;
- The presence of sever scars in the region of internal fistula opening, wide fistula opening > 5 mm;
- Crohn's fistulae
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-tract laser closure (FiLAC™)The procedure was performed with a diode laser platform emitting laser energy of 15 W at a wavelength of 1470 nm by means of a radial fiber. For obliteration, the fistula track is treated with a continuous slow retraction of the laser fibre withdrawn at a rate of approximately 1 cm per 2-3s. | Procedure or surgery | Fistula-tract laser closure (FiLAC™) |
| Monopolar coagulation of fistulous tractThe procedure was performed with a monopolar coagulator platform emitting monopolar coagulation. For obliteration, the fistula track is treated with a continuous slow retraction of the monopolar energy with suturing the internal fistulas opening. | Procedure or surgery | Fistula monopolar cogulation |
Primary outcome
Rate of healing
Time frame: 60 days
healing
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2018.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fistula-tract laser closure (FiLAC™) and Monopolar coagulation of fistulous tract in people with Anal Fistula, run by State Scientific Centre of Coloproctology, Russian Federation at 1 site in Russia.
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 5 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: status not confirmed, as of the sponsor's last update on 14 Nov 2018. 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 Russia. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ivan Kostarev, MD (+7-499-199-63-98, djovani_80@mail.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of healing (time frame: 60 days). 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 14 Nov 2018.