Ignite Creation Date:
2025-12-25 @ 3:53 AM
Ignite Modification Date:
2026-03-06 @ 6:07 AM
Study NCT ID:
NCT03679702
Status:
UNKNOWN
Last Update Posted:
2018-11-21
First Post:
2018-09-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Viveve Experience Normalizes Untreated Selective Serotonin Reuptake Inhibitor (SSRI) Sexuality Syndrome
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2018-12-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2019-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-11-19', 'studyFirstSubmitDate': '2018-09-19', 'studyFirstSubmitQcDate': '2018-09-19', 'lastUpdatePostDateStruct': {'date': '2018-11-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-09-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety - Adverse Events', 'timeFrame': 'baseline to 6 month', 'description': 'safety of treatment of female sexual dysfunction secondary to SSRI sexuality syndrome'}], 'secondaryOutcomes': [{'measure': 'Female Sexual Function Index (FSFI)', 'timeFrame': 'baseline to 3 and 6 months', 'description': 'Female Sexual Function Index total score (Minimum: 2.0) (Maximum: 36), Higher scores are better outcome.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Sexual Dysfunction']}, 'descriptionModule': {'briefSummary': 'A pilot study to investigate non-surgical treatment for women who suffer from sexual complaints secondary to SSRI Sexuality Syndrome.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Currently using SSRI for 3 months at a stable dose\n\nExclusion Criteria:\n\n* Pregnant, currently breastfeeding, or breast-fed within the last 6 months\n* Has any implantable electrical device that could potentially be affected by use of radiofrequency.'}, 'identificationModule': {'nctId': 'NCT03679702', 'acronym': 'VENUSSSS', 'briefTitle': 'A Viveve Experience Normalizes Untreated Selective Serotonin Reuptake Inhibitor (SSRI) Sexuality Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Southern California Center for Sexual Health and Survivorship Medicine'}, 'officialTitle': 'A Viveve Experience Normalizes Untreated Selective Serotonin Reuptake Inhibitor (SSRI) Sexuality Syndrome', 'orgStudyIdInfo': {'id': 'VI-ISRP-034'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Active treatment', 'interventionNames': ['Device: Viveve System']}], 'interventions': [{'name': 'Viveve System', 'type': 'DEVICE', 'description': 'Radiofrequency device utilized in general surgical procedures for electrocoagulation and hemostasis.', 'armGroupLabels': ['Active treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92663', 'city': 'Newport Beach', 'state': 'California', 'country': 'United States', 'contacts': [{'name': 'Michael Krychman, MD', 'role': 'CONTACT', 'email': 'mkrychman@icloud.com', 'phone': '949-764-9300'}, {'name': 'Michael Krychman, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Southern California Center for Sexual Health and Survivorship Medicine', 'geoPoint': {'lat': 33.61891, 'lon': -117.92895}}], 'centralContacts': [{'name': 'Michael Krychman', 'role': 'CONTACT', 'email': 'mkrychman@icloud.com', 'phone': '949-764-9300'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Michael Krychman, MD', 'class': 'OTHER'}, 'collaborators': [{'name': 'Viveve Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Michael Krychman, MD', 'investigatorFullName': 'Michael Krychman, MD', 'investigatorAffiliation': 'Southern California Center for Sexual Health and Survivorship Medicine'}}}}