Ignite Creation Date:
2025-12-24 @ 10:23 PM
Ignite Modification Date:
2025-12-28 @ 3:37 AM
Study NCT ID:
NCT01090635
Status:
COMPLETED
Last Update Posted:
2011-02-04
First Post:
2010-03-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Imaging the Uterine Cervix - UltraSightHD™
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002583', 'term': 'Uterine Cervical Neoplasms'}, {'id': 'D002578', 'term': 'Uterine Cervical Dysplasia'}], 'ancestors': [{'id': 'D014594', 'term': 'Uterine Neoplasms'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D002577', 'term': 'Uterine Cervical Diseases'}, {'id': 'D014591', 'term': 'Uterine 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': 'D011230', 'term': 'Precancerous Conditions'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-02', 'completionDateStruct': {'date': '2011-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-02-03', 'studyFirstSubmitDate': '2010-03-18', 'studyFirstSubmitQcDate': '2010-03-19', 'lastUpdatePostDateStruct': {'date': '2011-02-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-03-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-02', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Cervical Intraepithelial Neoplasia'], 'conditions': ['Uterine Cervical Neoplasms']}, 'descriptionModule': {'briefSummary': "The purpose of this study is to investigate the performance ability of the UltraSightHD™. The instrument will be assessed on characteristics such as focus quality, ability to image the entire cervix, and illumination. The information gathered from this study will provide data that will be used to determine which settings provide the best imaging outcome for the cervix for a simple screening instrument. Further, this information will serve as the foundation in the development of more advanced follow-on imaging devices.\n\nThe primary objectives of this study are to:\n\n* Determine if the light source provides sufficient illumination of the cervix.\n* Assess focus and overall image quality.\n* Assess the functionality and ergonomics of the instrument's design."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Healthy non-pregnant females over 18 years old.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy Female\n* 18 years old or older\n* Not pregnant\n* Ability to give consent\n\nExclusion Criteria:\n\n* Male\n* Less than 18 years old\n* Pregnant or suspected pregnancy'}, 'identificationModule': {'nctId': 'NCT01090635', 'briefTitle': 'Imaging the Uterine Cervix - UltraSightHD™', 'organization': {'class': 'INDUSTRY', 'fullName': 'STI-Medical Systems'}, 'officialTitle': 'Imaging the Uterine Cervix - UltraSightHD™', 'orgStudyIdInfo': {'id': '2010-1'}}, 'contactsLocationsModule': {'locations': [{'zip': '96813', 'city': 'Honolulu', 'state': 'Hawaii', 'country': 'United States', 'facility': 'Dr. Nathan Fujita', 'geoPoint': {'lat': 21.30694, 'lon': -157.85833}}], 'overallOfficials': [{'name': 'Nathan Fujita, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'STI-Medical Systems', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Rolf Wolters, Sr. VP.', 'oldOrganization': 'STI- Medical Systems'}}}}