Ignite Creation Date:
2025-12-24 @ 11:08 PM
Ignite Modification Date:
2025-12-25 @ 8:41 PM
Study NCT ID:
NCT05097469
Status:
UNKNOWN
Last Update Posted:
2022-04-20
First Post:
2021-10-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Carbon Dioxide Acupulse Laser Treatment Versus Sham Treatment and Sexual Dysfunction.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012735', 'term': 'Sexual Dysfunction, Physiological'}], 'ancestors': [{'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D054020', 'term': 'Lasers, Gas'}], 'ancestors': [{'id': 'D007834', 'term': 'Lasers'}, {'id': 'D055096', 'term': 'Optical Devices'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D055618', 'term': 'Radiation Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-10-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2023-11-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-04-19', 'studyFirstSubmitDate': '2021-10-04', 'studyFirstSubmitQcDate': '2021-10-19', 'lastUpdatePostDateStruct': {'date': '2022-04-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-10-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Vaginal health index', 'timeFrame': 'From treatment up to 12 months post treatment', 'description': 'Change in total and specific vaginal health index scores'}], 'secondaryOutcomes': [{'measure': 'Female sexual function index', 'timeFrame': 'From treatment up to 12 months post treatment', 'description': 'Change in total and specific female sexual function index questionnaire scores'}, {'measure': 'Sexual intercourse', 'timeFrame': 'From treatment up to 12 months post treatment', 'description': 'Change in monthly sexual intercourse rate'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Sexual Dysfunction']}, 'descriptionModule': {'briefSummary': 'The study is intended to assess the safety and efficacy of Carbon dioxide AcuPulse laser treatment in patients with sexual dysfunction. Eligible subjects will be randomized to either receive 3 laser or 3 sham treatment sessions, 4 weeks apart and 3 follow up visits 3, 6 and 12 months following the last treatment.', 'detailedDescription': "Following a screening visit, eligible subjects will be enrolled into the study. Subjects will be randomized into either laser treatment or sham treatment. Each subject will receive 3 treatments 4 weeks apart and 3 follow up visits, at 3, 6 and 12 months following the last treatment.\n\nFurther demographic information and patient history will be obtained from the subjects' electronic files."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '30 Years', 'genderBased': True, 'genderDescription': 'Female patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Negative urine analysis.\n* Normal Pap smear test from the recent 3 years.\n* No previous gynecological laser treatments.\n* Able and willing to comply with the treatment/follow-up schedule and requirements.\n\nExclusion Criteria:\n\n* Active genital infection.\n* Subject presenting abnormal Pap result from the last three years.\n* Recurring urinary tract infection or recurring infection of genital herpes or candida (\\> 2 episodes in the recent year).\n* Transvaginal mesh implant.\n* Serious systemic disease or any chronic condition that could interfere with study compliance.\n* Any vaginal bleeding of unknown reason.'}, 'identificationModule': {'nctId': 'NCT05097469', 'briefTitle': 'Carbon Dioxide Acupulse Laser Treatment Versus Sham Treatment and Sexual Dysfunction.', 'organization': {'class': 'OTHER', 'fullName': 'Rambam Health Care Campus'}, 'officialTitle': 'Randomized, Double-blind, Sham-controlled Clinical Trial for Evaluating the Efficacy of Fractional Carbon Dioxide Laser in the Treatment of Female Sexual Dysfunction.', 'orgStudyIdInfo': {'id': '0290-20-RMB'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Laser treatment', 'description': 'Carbon dioxide laser treatment', 'interventionNames': ['Device: Carbon dioxide laser']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham treatment', 'description': 'Sham laser treatment', 'interventionNames': ['Device: Sham laser treatment']}], 'interventions': [{'name': 'Carbon dioxide laser', 'type': 'DEVICE', 'description': '3 consecutive sessions of carbon dioxide laser treatment', 'armGroupLabels': ['Laser treatment']}, {'name': 'Sham laser treatment', 'type': 'DEVICE', 'description': '3 consecutive sessions of sham laser treatment', 'armGroupLabels': ['Sham treatment']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Haifa', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Roy Lauterbach, MD', 'role': 'CONTACT', 'email': 'r_lauterbach@rambam.health.gov.il', 'phone': '0529432416'}], 'facility': 'Rambam health care campus', 'geoPoint': {'lat': 32.81303, 'lon': 34.99928}}], 'centralContacts': [{'name': 'Roy Lauterbach, MD', 'role': 'CONTACT', 'email': 'r_lauterbach@rambam.health.gov.il', 'phone': '+972-52-9432416'}], 'overallOfficials': [{'name': 'Roy Lauterbach, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rambam healthcare campus'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rambam Health Care Campus', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'ROY LAUTERBACH MD', 'investigatorAffiliation': 'Rambam Health Care Campus'}}}}