Ignite Creation Date:
2025-12-24 @ 7:48 PM
Ignite Modification Date:
2025-12-28 @ 8:35 PM
Study NCT ID:
NCT04816903
Status:
UNKNOWN
Last Update Posted:
2021-03-25
First Post:
2021-03-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Gyni™ Study With Leumit Health Services
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014627', 'term': 'Vaginitis'}], 'ancestors': [{'id': 'D014623', 'term': 'Vaginal 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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'Group-A Blinded Group-B Unblinded'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 600}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-03-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2022-03-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-03-24', 'studyFirstSubmitDate': '2021-03-22', 'studyFirstSubmitQcDate': '2021-03-24', 'lastUpdatePostDateStruct': {'date': '2021-03-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparison parameter', 'timeFrame': '12 months', 'description': 'Number of visits (from initial visit until the cause of vaginitis is detected)'}, {'measure': 'Comparison parameter', 'timeFrame': '12 months', 'description': 'Total cost of medication'}, {'measure': 'Comparison parameter', 'timeFrame': '12 months', 'description': 'Total Cost of lab tests'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['gynecology', 'IVD'], 'conditions': ['Vaginitis']}, 'descriptionModule': {'briefSummary': 'About one third of the women referring to gynecological clinics present with vulvovaginal inflammation symptoms (vaginitis) possibly caused by seven different conditions or mixed infections. The Gyni™ system is intended to provide physicians with the means to obtain an accurate, fast and inexpensive diagnosis which is unavailable today.\n\nGyni™ is comprised of a compact tabletop scanner, a disposable sample collector and a cloud based algorithm that provides a suggested diagnosis within 5 minutes.\n\nThe trial is a prospective evaluation of the cost-effectiveness of using Gyni™ by comparing its usage outcomes in a practice setting to the outcomes obtained using the current standard of care.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Females', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female ≥18 years old\n* Able to read, understand and sign an informed consent form\n* At least one of the following: abnormal vaginal discharge, odor, vulvovaginal itch, burning, irritation, dyspareunia, vaginal dryness or pain.\n\nExclusion Criteria:\n\n* Patients under the age of 18 years\n* Patient is unfit to provide an informed consent\n* Patient with vaginal bleeding, including menstruation within past 24 hours21\n* Patient who used intra vaginal preparations within 72 hours prior to study enrollment (antimicrobials, spermicides, lubricants, diaphragm)22\n* Uninterpretable sample (e.g. patients who used vaginal creams or lubricants before the visit or insufficient sampling material)'}, 'identificationModule': {'nctId': 'NCT04816903', 'briefTitle': 'Gyni™ Study With Leumit Health Services', 'organization': {'class': 'INDUSTRY', 'fullName': 'GynTools Ltd.'}, 'officialTitle': 'Gyni™ System Pilot Study With Leumit Health Services - Prospective Study', 'orgStudyIdInfo': {'id': 'CL00000-16'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Symptomatic vaginitis patients', 'description': 'All participants will be enrolled according to their complaints, All will be tested by the Gyni system, Only in the second group the physician will be unblinded to the Gyni results.', 'interventionNames': ['Diagnostic Test: Gyni']}], 'interventions': [{'name': 'Gyni', 'type': 'DIAGNOSTIC_TEST', 'description': 'Vaginal discharge collection', 'armGroupLabels': ['Symptomatic vaginitis patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4240200', 'city': 'Netanya', 'state': 'Central District', 'status': 'NOT_YET_RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Amir L Weintraub, MD', 'role': 'CONTACT', 'phone': '+972508685330'}], 'facility': "Netanya Women's health center, Leumit Health services (HMO)", 'geoPoint': {'lat': 32.33291, 'lon': 34.85992}}, {'zip': '2490800', 'city': 'Kfar Yasif', 'state': 'North', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Marwan Odeh, MD', 'role': 'CONTACT', 'phone': '972507887486'}], 'facility': 'Kfar Yasif clinic', 'geoPoint': {'lat': 32.95451, 'lon': 35.1623}}, {'zip': '2709325', 'city': 'Kiryat Bialik', 'state': 'North', 'status': 'NOT_YET_RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Lior Lowenstein, Professor', 'role': 'CONTACT', 'phone': '972502061434'}], 'facility': "Kiryat Bialik, Leumit health services (HMO) Women's health clinic", 'geoPoint': {'lat': 32.8275, 'lon': 35.08583}}, {'zip': '9439000', 'city': 'Jerusalem', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Avishai Malkiel, MD', 'role': 'CONTACT', 'phone': '972587424564'}], 'facility': "Leumit women's health", 'geoPoint': {'lat': 31.76904, 'lon': 35.21633}}], 'centralContacts': [{'name': 'Yardenna Glader', 'role': 'CONTACT', 'email': 'yardenna@gyntools.com', 'phone': '+972525522116'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GynTools Ltd.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Leumit Health Services', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}