Ignite Creation Date:
2025-12-25 @ 3:38 AM
Ignite Modification Date:
2025-12-26 @ 2:23 AM
Study NCT ID:
NCT01409902
Status:
COMPLETED
Last Update Posted:
2013-04-23
First Post:
2011-08-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Using a Sheathed Speculum to Visualize and Access the Cervix In Women With Excessive Vaginal Tissue
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014596', 'term': 'Uterine Prolapse'}], 'ancestors': [{'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': 'D056887', 'term': 'Pelvic Organ Prolapse'}, {'id': 'D011391', 'term': 'Prolapse'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 38}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-04', 'completionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-04-22', 'studyFirstSubmitDate': '2011-08-02', 'studyFirstSubmitQcDate': '2011-08-03', 'lastUpdatePostDateStruct': {'date': '2013-04-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-08-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of patients with adequate visualization and access to cervix or vaginal vault', 'timeFrame': 'At time of speculum exam'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Vaginal Prolapse']}, 'descriptionModule': {'briefSummary': "The main objective of the study is to assess the effectiveness of the sheathed speculum in providing adequate visualization and access to the cervix in patients with excessive vaginal tissue.\n\nThe secondary objective is to rate the patient's comfort evaluation during the sheathed speculum examination.", 'detailedDescription': 'This is a descriptive clinical trial designed to assess the efficacy of a sheathed speculum in providing adequate visualization and access to the cervix in women with excessive vaginal tissue. Eligible, consented subjects who fail their initial speculum examination (because their cervix is not visualized due to the collapse of loose lateral vaginal walls) will have a sheathed speculum examination instead of the standard-of-care exam whereby the clinician fabricates a solution at the bedside (condom with tip cut placed on speculum, concomitantly using an additional instrument like a lateral-wall retractor, glove with tip of thumb placed over the speculum, using the largest speculum available)'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'excessive vaginal tissue', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age 18 to 64 years\n* BMI greater than 30 (or see next line)\n* Collapsing vaginal tissue preventing the visualization of the cervix (meeting this criterion in the absence of a BMI \\>30 would also qualify the patient for the study).\n* Able to provide written informed consent\n\nExclusion Criteria:\n\n* Patients unwilling to participate in the study or provide consent Presence of significant acute pelvic pain syndromes (ie exacerbation of dyspareunia, chronic pelvic pain or pelvic floor dysfunction, atrophic vaginitis, interstitial cystitis, endometriosis) which, in the opinion of the examining clinician, could potentially confound the patient's responses to the questionnaire\n* Presence of active genital herpes\n* Presence of significant condyloma acuminata (may be an investigator decision)\n* Any other patient deemed inappropriate for the study by the consenting or examining investigator."}, 'identificationModule': {'nctId': 'NCT01409902', 'briefTitle': 'Using a Sheathed Speculum to Visualize and Access the Cervix In Women With Excessive Vaginal Tissue', 'organization': {'class': 'OTHER', 'fullName': 'University of South Florida'}, 'officialTitle': 'Using a Sheathed Speculum to Visualize and Access the Cervix In Women With Excessive Vaginal Tissue', 'orgStudyIdInfo': {'id': '105827'}}, 'contactsLocationsModule': {'locations': [{'zip': '33549', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'USF STC', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}], 'overallOfficials': [{'name': 'Erich Wyckoff, M', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of South Florida'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of South Florida', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}