Treatment of Transsphicteric Fistula-in-ano by Method of Laser Thermoobliteration(FiLaC™).
NCT ID: NCT03690934
Last Updated: 2018-11-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
120 participants
INTERVENTIONAL
2017-10-23
2020-08-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Fistula Laser Closure
NCT03297138
LASER FiLaC™ (FISTULA LASER CLOSURE) : First-line Treatment of Complex Anal Fistulas
NCT05201209
Comparison Between Laser and Open Fistula Surgeries in the Management of Fistula - In - Ano
NCT07083778
Treatment of Anal Fistula With Lasercoagulation
NCT03017898
Laser Closure of Anal Fistula (FiLaC)
NCT04161469
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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-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 For obliteration, the fistula track is treated with a continuous slow retraction of the laser fibre withdrawn at a rate of approximately 1 cm per 2-3s.
Fistula monopolar cogulation
The treatment technicque consists of monopolar coagulation of fistulous tract walls with suturing the internal fistulas opening.
Monopolar coagulation of fistulous tract
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Monopolar coagulation of fistulous tract
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Patients with high transsphincteric fistula (\>1/3), suprasphincteric fistula whithout abscesses;
3. The presence of a formed fistulous tract \> 2 cm in length.
Exclusion Criteria
2. Extrasphincteric fistula;
3. Length of fistula tract \< 2 cm;
4. The presence of sever scars in the region of internal fistula opening, wide fistula opening \> 5 mm;
5. Crohn's fistulae
18 Years
90 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
State Scientific Centre of Coloproctology, Russian Federation
OTHER_GOV
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
State Scientific Centre of Coloproctology
Moscow, , Russia
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Ivan Kostarev, MD
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
74
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.