Ignite Creation Date:
2025-12-24 @ 4:15 PM
Ignite Modification Date:
2025-12-25 @ 2:13 PM
Study NCT ID:
NCT05250466
Status:
UNKNOWN
Last Update Posted:
2024-02-05
First Post:
2022-02-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Comparative Study on the Efficacy of AI Temperature-controlled Radiofrequency Technology and Electrical Stimulation in the Treatment of Vulvar Leukoplakia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007724', 'term': 'Vulvar Lichen Sclerosus'}], 'ancestors': [{'id': 'D014845', 'term': 'Vulvar Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004558', 'term': 'Electric Stimulation'}], 'ancestors': [{'id': 'D010812', 'term': 'Physical Stimulation'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-07-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2024-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-01', 'studyFirstSubmitDate': '2022-02-10', 'studyFirstSubmitQcDate': '2022-02-10', 'lastUpdatePostDateStruct': {'date': '2024-02-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy index', 'timeFrame': '6 month after treatment', 'description': 'Efficacy index: (score before treatment-score after treatment)/(score before treatment)×100%'}], 'secondaryOutcomes': [{'measure': 'Recurrence rate', 'timeFrame': '6 month after treatment', 'description': 'Percentage of recurrence of genital itching 6 months after treatment'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Vulvar Lichen Sclerosus']}, 'descriptionModule': {'briefSummary': 'The study was designed as a prospective, multicenter, randomized, open-label, parallel-controlled clinical trial. The study population was patients with vulvar leukoplakia, and compared the efficacy and safety of AI temperature-controlled radio frequency technology and electrical stimulation in the treatment of vulvar leukoplakia. According to the research purpose, the sample size was calculated and determined to be 120 cases, and they were randomly assigned to the observation group and the control group according to the ratio of 1:1, namely 60 cases in the radio frequency observation group and 60 cases in the electric stimulation control group.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Diagnosed by pathological examination, meeting the diagnostic criteria for leukoplakia;\n2. 18 to 60 years old;\n3. Agree to sign the informed consent;\n\nExclusion Criteria:\n\n1. Patients with severe liver and kidney dysfunction;\n2. Combined with HIV, syphilis infection, acute vaginitis, cervical cancer;\n3. Patients with cardiovascular disease;\n4. People with hematological diseases;\n5. Patients with hypertension and diabetes;\n6. People with mental illness;\n7. Pregnant and lactating women.'}, 'identificationModule': {'nctId': 'NCT05250466', 'briefTitle': 'A Comparative Study on the Efficacy of AI Temperature-controlled Radiofrequency Technology and Electrical Stimulation in the Treatment of Vulvar Leukoplakia', 'organization': {'class': 'OTHER', 'fullName': 'Zhongnan Hospital'}, 'officialTitle': 'A Comparative Study on the Efficacy of AI Temperature-controlled Radiofrequency Technology and Electrical Stimulation in the Treatment of Vulvar Leukoplakia', 'orgStudyIdInfo': {'id': 'vulvar leukoplakia 2022'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Radiofrequency group', 'description': 'AI Temperature-controlled Radiofrequency Technology', 'interventionNames': ['Procedure: Radiofrequency technology']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Electrical stimulation group', 'description': 'Electrical Stimulation', 'interventionNames': ['Procedure: Electrical stimulation']}], 'interventions': [{'name': 'Radiofrequency technology', 'type': 'PROCEDURE', 'description': "The vulva and vagina were routinely disinfected with iodophor, the negative plate was placed on the patient's waist and abdomen, and the vulva module was selected for treatment for 10 minutes per side, for a total of 20 minutes. Parameters: power 10-20W, temperature 38-42C°, once every 10 days, 5 times in total", 'armGroupLabels': ['Radiofrequency group']}, {'name': 'Electrical stimulation', 'type': 'PROCEDURE', 'description': 'Routine vulvovaginal disinfection with iodophor, vaginal probes are placed in channel A, electrode pads are placed in channels B\\\\C\\\\D respectively, the frequency of electrical stimulation (the most comfortable amount) is adjusted, 10 times is a course of treatment, and mild lesions are treated for 1-2 courses of treatment , 2 to 3 courses of treatment for moderate to severe lesions.', 'armGroupLabels': ['Electrical stimulation group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Wuhan', 'state': 'Hubei', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yuanzhen Zhang', 'role': 'CONTACT'}, {'name': 'Yuanzhen Zhang', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Zhongnan Hospital of Wuhan University', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}], 'centralContacts': [{'name': 'Yuanzhen Zhang, professor', 'role': 'CONTACT', 'email': 'wdzn2019@163.com', 'phone': '+86 13545364853'}, {'name': 'Kejia Wu, Doctor', 'role': 'CONTACT', 'email': 'wdzn2019@163.com', 'phone': '+86 13545364853'}], 'overallOfficials': [{'name': 'Yuanzhen Zhang, Professor', 'role': 'STUDY_CHAIR', 'affiliation': 'Wuhan University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zhongnan Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}