Ignite Creation Date:
2025-12-25 @ 2:29 AM
Ignite Modification Date:
2026-02-09 @ 1:44 AM
Study NCT ID:
NCT03690934
Status:
UNKNOWN
Last Update Posted:
2018-11-14
First Post:
2018-09-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treatment of Transsphicteric Fistula-in-ano by Method of Laser Thermoobliteration(FiLaC™).
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012003', 'term': 'Rectal Fistula'}], 'ancestors': [{'id': 'D007412', 'term': 'Intestinal Fistula'}, {'id': 'D016154', 'term': 'Digestive System Fistula'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}, {'id': 'D005402', 'term': 'Fistula'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Assignment'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-10-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2020-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-11-13', 'studyFirstSubmitDate': '2018-09-12', 'studyFirstSubmitQcDate': '2018-09-28', 'lastUpdatePostDateStruct': {'date': '2018-11-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-10-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of healing', 'timeFrame': '60 days', 'description': 'healing'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Anal Fistula']}, 'descriptionModule': {'briefSummary': 'This is a randomized, controlled, parallel study to compare the results of treatment for patients with transsphincteric fistulas-in-ano.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Informed consent to the study;\n2. Patients with high transsphincteric fistula (\\>1/3), suprasphincteric fistula whithout abscesses;\n3. The presence of a formed fistulous tract \\> 2 cm in length.\n\nExclusion Criteria:\n\n1. Suprasphincteric fistula with abscesses or infiltrates;\n2. Extrasphincteric fistula;\n3. Length of fistula tract \\< 2 cm;\n4. The presence of sever scars in the region of internal fistula opening, wide fistula opening \\> 5 mm;\n5. Crohn's fistulae"}, 'identificationModule': {'nctId': 'NCT03690934', 'briefTitle': 'Treatment of Transsphicteric Fistula-in-ano by Method of Laser Thermoobliteration(FiLaC™).', 'organization': {'class': 'OTHER_GOV', 'fullName': 'State Scientific Centre of Coloproctology, Russian Federation'}, 'officialTitle': 'Randomized Conrtolled Study: Fistula Laser Closure (FiLaC™) vs Monopolar Coagulation for Treatment of Complex Anal Fistulae.', 'orgStudyIdInfo': {'id': '74'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Fistula-tract laser closure (FiLAC™)', 'description': '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.', 'interventionNames': ['Procedure: Fistula-tract laser closure (FiLAC™)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Fistula monopolar cogulation', 'description': 'The treatment technicque consists of monopolar coagulation of fistulous tract walls with suturing the internal fistulas opening.', 'interventionNames': ['Procedure: Monopolar coagulation of fistulous tract']}], 'interventions': [{'name': 'Fistula-tract laser closure (FiLAC™)', 'type': 'PROCEDURE', 'description': '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.', 'armGroupLabels': ['Fistula-tract laser closure (FiLAC™)']}, {'name': 'Monopolar coagulation of fistulous tract', 'type': 'PROCEDURE', 'description': '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.', 'armGroupLabels': ['Fistula monopolar cogulation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '123423', 'city': 'Moscow', 'status': 'RECRUITING', 'country': 'Russia', 'contacts': [{'name': 'Ivan Kostarev, MD', 'role': 'CONTACT'}], 'facility': 'State Scientific Centre of Coloproctology', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}], 'centralContacts': [{'name': 'Ivan Kostarev, MD', 'role': 'CONTACT', 'email': 'djovani_80@mail.ru', 'phone': '+7-499-199-63-98'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'State Scientific Centre of Coloproctology, Russian Federation', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}