Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2025-12-26 @ 2:11 AM
Study NCT ID:
NCT04219605
Status:
COMPLETED
Last Update Posted:
2025-05-13
First Post:
2020-01-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of a Rapid Microscopic Diagnostic System for Different Vaginitis Conditions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016585', 'term': 'Vaginosis, Bacterial'}, {'id': 'D002181', 'term': 'Candidiasis, Vulvovaginal'}, {'id': 'D014247', 'term': 'Trichomonas Vaginitis'}, {'id': 'D059268', 'term': 'Atrophic Vaginitis'}], 'ancestors': [{'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014627', 'term': 'Vaginitis'}, {'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'}, {'id': 'D002177', 'term': 'Candidiasis'}, {'id': 'D009181', 'term': 'Mycoses'}, {'id': 'D014848', 'term': 'Vulvovaginitis'}, {'id': 'D014847', 'term': 'Vulvitis'}, {'id': 'D014845', 'term': 'Vulvar Diseases'}, {'id': 'D014245', 'term': 'Trichomonas Infections'}, {'id': 'D011528', 'term': 'Protozoan Infections'}, {'id': 'D010272', 'term': 'Parasitic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 226}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2023-03-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-08', 'studyFirstSubmitDate': '2020-01-05', 'studyFirstSubmitQcDate': '2020-01-05', 'lastUpdatePostDateStruct': {'date': '2025-05-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diagnostic performance', 'timeFrame': '12 months', 'description': 'Specificity and sensitivity of the device performance in regard to vaginitis conditions'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Bacterial Vaginosis', 'Candida Albicans Vulvovaginitis', 'Candida Vulvovaginitis', 'Trichomonas Vaginitis', 'Atrophic Vaginitis', 'Desquamative Inflammatory Vaginitis']}, 'referencesModule': {'references': [{'pmid': '37055473', 'type': 'BACKGROUND', 'citation': 'Lev-Sagie A, Strauss D, Ben Chetrit A. Diagnostic performance of an automated microscopy and pH test for diagnosis of vaginitis. NPJ Digit Med. 2023 Apr 13;6(1):66. doi: 10.1038/s41746-023-00815-w.'}]}, 'descriptionModule': {'briefSummary': 'Evaluate the diagnostic performance of the Gyni™ device to detect different vaginitis conditions by comparison to microscopic diagnosis and related lab tests.', 'detailedDescription': 'During gynecological exams, vaginal discharge samples will be are taken for testing the pH level, microscopic examination and laboratory examinations (vaginal cultures and sexually transmitted infections).\n\nOne additional sample will be taken intended for the Gyni™ system diagnosis. This additional examination will be performed in the clinic by pulling the cytobrush through a dedicated cartridge and scanning it in the Gyni table-top scanner. The result diagnosis will be anonymously kept in the cloud.\n\nThe diagnosis suggested by the Gyni system will not be visible to the physician in order to prevent any bias. Results from the physician, from the device and from the lab will be summarized and compared by the chief investigator'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with vulvovaginal symptoms', 'genderDescription': 'The study examine a diagnostic test for vaginal inflammations (vaginitis) which is only applicable to female patients.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women with vaginal complaints: Discharge, Malodor, Itching, Irritation, Dyspareunia, Pain\n* Age \\>= 18y\n\nExclusion Criteria:\n\n* Age \\< 18y\n* Not eligible to sign an informed consent\n* Vaginal discharge samples found microscopically not interpret-able by the investigator due to patient using vaginal creams, ointments, lubricants or sperm presence.\n* During menstruation'}, 'identificationModule': {'nctId': 'NCT04219605', 'briefTitle': 'Evaluation of a Rapid Microscopic Diagnostic System for Different Vaginitis Conditions', 'organization': {'class': 'OTHER', 'fullName': 'Meir Medical Center'}, 'officialTitle': 'Evaluation of a Rapid Microscopic Diagnostic System for Different Vaginitis Conditions', 'orgStudyIdInfo': {'id': '0120-19-COM1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Symptomatic vaginitis patients', 'description': 'Symptomatic patients evaluated in the clinic for vulvovaginal symptoms.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Jerusalem', 'state': 'Jerusalem', 'country': 'Israel', 'facility': 'Clalit HMO', 'geoPoint': {'lat': 31.76904, 'lon': 35.21633}}], 'overallOfficials': [{'name': 'Avraham Ben Chetrit, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Clalit HMO'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Meir Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}