Ignite Creation Date:
2025-12-24 @ 2:58 PM
Ignite Modification Date:
2026-02-28 @ 8:45 PM
Study NCT ID:
NCT03667859
Status:
COMPLETED
Last Update Posted:
2020-09-16
First Post:
2018-09-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vaginal Elasticity Assessment Before and After Brachytherapy/Pelvic Radiation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011832', 'term': 'Radiation Injuries'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2020-08-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-12', 'studyFirstSubmitDate': '2018-09-10', 'studyFirstSubmitQcDate': '2018-09-11', 'lastUpdatePostDateStruct': {'date': '2020-09-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-09-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-07-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Vaginal elasticity assessment', 'timeFrame': 'up to 6 months from enrollment', 'description': 'Vaginal elasticity as measured by the vaginal tactile imager.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Radiation Injuries']}, 'descriptionModule': {'briefSummary': 'Female patients with either uterine/cervical malignancies will be evaluated for vaginal elasticity using vaginal tactile imaging both before and after radiation treatment.', 'detailedDescription': "Patients will be recruited and sign a consent form. The patients included are patients with either uterine/cervical malignancies. Each participant undergoes radiation treatment either as primary or complementary treatment.\n\nAssessment of vaginal elasticity via vaginal tactile imaging will be performed at 3 different points:\n\n* Before the first treatment session (baseline).\n* After the last session of laser treatment.\n* 3 months post final treatment. Every patient will serve as her own control. Demographic, gynecologic and obstetric history will be obtained from patients' electronic files."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Women undergoing either brachytherapy or pelvic radiation treatment as primary or complementary treatment for a cervical/uterine malignancy.', 'genderDescription': 'Female patients with gynecological malignancies.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Any woman undergoing either brachytherapy or pelvic radiation treatment as primary or complementary treatment for a cervical/uterine malignancy.\n\nExclusion Criteria:\n\n* Women that are not in the age range.\n* Women with massive vaginal bleeding.\n* Women after pelvic exenteration.'}, 'identificationModule': {'nctId': 'NCT03667859', 'briefTitle': 'Vaginal Elasticity Assessment Before and After Brachytherapy/Pelvic Radiation', 'organization': {'class': 'OTHER', 'fullName': 'Rambam Health Care Campus'}, 'officialTitle': 'Vaginal Elasticity Assessment Before and After Brachytherapy/Pelvic Radiation as Measured by Vaginal Tactile Imaging', 'orgStudyIdInfo': {'id': '0398-18-RMB'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Women undergoing Brachytherapy', 'description': 'Women with either uterine or cervical malignancy treated primarily by brachytherapy.', 'interventionNames': ['Diagnostic Test: Vaginal Tactile Imaging']}, {'label': 'Women undergoing Pelvic Radiation', 'description': 'Women with either uterine or cervical malignancy treated primarily by pelvic radiation.', 'interventionNames': ['Diagnostic Test: Vaginal Tactile Imaging']}], 'interventions': [{'name': 'Vaginal Tactile Imaging', 'type': 'DIAGNOSTIC_TEST', 'description': 'Vaginal elasticity measurements using the Vaginal Tactile Imaging system.', 'armGroupLabels': ['Women undergoing Brachytherapy', 'Women undergoing Pelvic Radiation']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Haifa', 'country': 'Israel', 'facility': 'Rambam health care campus', 'geoPoint': {'lat': 32.81303, 'lon': 34.99928}}], 'overallOfficials': [{'name': 'Roy Lauterbach, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rambam Health Care Campus'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, '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'}}}}