Ignite Creation Date:
2025-12-24 @ 11:25 PM
Ignite Modification Date:
2025-12-25 @ 9:10 PM
Study NCT ID:
NCT05254756
Status:
TERMINATED
Last Update Posted:
2023-11-22
First Post:
2022-02-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
"Pilot Study: A Comparison of the Bouquet Speculum and the Traditional 2-Bladed Speculum"
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER'], 'maskingDescription': 'Patients who have an indication for a speculum exam and who meet other inclusion criteria will be randomized to either receive their exam with the traditional plastic 2-blade disposable speculum or the 5-petal Bouquet speculum. After the exam, the patient and the physician will each fill out a questionnaire that will ask about patient comfort, ease of use, visibility of the cervix, and perceived time of the exam.'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This randomized single-blinded clinical study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 13}}, 'statusModule': {'whyStopped': 'The study was stopped because of logistical issues with the sites.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2022-03-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2022-10-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-20', 'studyFirstSubmitDate': '2022-02-04', 'studyFirstSubmitQcDate': '2022-02-14', 'lastUpdatePostDateStruct': {'date': '2023-11-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient comfort', 'timeFrame': 'Immediately after the exam', 'description': 'Find the difference in the level of patient comfort during a vaginal speculum exam between the traditional 2-blade plastic disposable speculum and the 5-petal Bouquet speculum.\n\nAssessed with a questionnaire answered by the patient:\n\n1. What was the level of comfort with this Pap smear compared to other speculum exams you have had? (More comfortable, Same level of comfort/discomfort, Less comfortable )\n2. Based on what you anticipated the exam was:\n\n (More comfortable, As comfortable/uncomfortable, Less comfortable)\n3. On a scale from 0 to 10, what is the highest level of pain you experienced during the Pap smear/speculum exam? (10 being the worst pain you have ever experienced, and 0 being no pain)\n4. Did the doctor who performed the exam ask you adjust your body position while the speculum was inserted? (Yes, No)\n5. What is your estimation of how long the speculum was inserted? (0-30 seconds, 30-60 seconds, 1-2 minutes, 2-3 minutes, \\>3 minutes)'}, {'measure': 'Length of time', 'timeFrame': 'During the exam', 'description': 'Find the difference in the length of time that the Bouquet speculum is inserted during a Pap smear compared to the traditional 2-blade speculum.\n\nThe time the speculum is inserted is recorded for every interactions.'}, {'measure': 'Ease of use', 'timeFrame': 'Immediately after the exam', 'description': 'Find the difference in ease of use for the provider between the traditional 2-blade plastic disposable speculum and the 5-petal Bouquet speculum.\n\nAssessed with a questionnaire answered by the provider:\n\n1. During the speculum exam, were the lateral walls of the cervix easily visualized upon initial visualization of the cervix? (Yes, No)\n2. What is your estimate of how long the speculum was inserted? (0-30 seconds, 30-60 seconds, 1-2 minutes, 2-3 minutes, \\>3 minutes)\n3. While the speculum was inserted, was the patient asked to adjust body position in order to gain a better view of the cervix? (Yes, No)\n4. Were special maneuvers performed in order to better visualize the cervix? (e.g. use a different size/type of speculum, apply a condom over the speculum to view the lateral walls, re-insert the speculum, etc.)? (Yes, No)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Pelvic Exam']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': "Bouquet JM, Chernau A, McLaughlin R, Choudhury Q. 2019. A New Vaginal Speculum and an Inexpensive Kit to Screen and Treat Dysplasia and Cancer of the Cervix. Journal of Women's Health Care. 8.470 doi: 10.35248/2167-0420.19.8.470"}]}, 'descriptionModule': {'briefSummary': 'This randomized single-blinded clinical study will compare the typical 2-bladed plastic disposable vaginal speculum to the novel 5-petal Bouquet speculum on level of patient comfort, visibility of the cervix, and time length of the examination. The data will be collected via patient and provider questionnaires.', 'detailedDescription': 'For nearly 200 years, the traditional 2-blade "Duck bill" vaginal speculum has had very little evolution in design. In past decades, there has been an increase in popularity in using the plastic speculum rather than the metal speculum. The plastic speculum has effectively the same design as the traditional metal vaginal speculum. The current 2-blade design that has been used for centuries leaves many women feeling pain or discomfort during a speculum vaginal exam. Furthermore, in obese and multiparous women, the 2-blade design often allows the lateral walls of the vagina to cave inward during the exam, preventing the provider from gaining full visibility of the cervix. Another common complaint is that the exam takes too long, which leaves patients in pain and feeling vulnerable for an extended period of time.\n\nThe novel 5-petal Bouquet vaginal speculum offers an alternative design that some have argued provides enhanced patient comfort, better visualization of the cervix, and is easier to use for the provider. This proposed study design is a blueprint that will be used to compare the Bouquet speculum to a traditional 2-blade disposable plastic speculum on patient comfort, visualization of the cervix, and ease of use for the provider. The investigators predict that the results of this study will help physicians and other medical providers provide patients with better experience, reducing or eliminating the current common complaints regarding how speculum exams are performed today.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female patients that require a pelvic exam.\n* 18 years of age or older\n* Having had at least one previous pelvic exam with the traditional speculum\n* Consent to participate in the study\n\nExclusion Criteria:\n\n\\- Never had a pelvic exam before'}, 'identificationModule': {'nctId': 'NCT05254756', 'briefTitle': '"Pilot Study: A Comparison of the Bouquet Speculum and the Traditional 2-Bladed Speculum"', 'organization': {'class': 'OTHER', 'fullName': 'Rocky Vista University, LLC'}, 'officialTitle': '"A Comparison of the Bouquet Speculum and the Traditional 2-Bladed Speculum"', 'orgStudyIdInfo': {'id': 'IRB #2020--0110'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Traditional plastic 2-blade disposable speculum', 'description': 'Patients assigned to this arm will be evaluated using the traditional plastic 2-blade disposable speculum', 'interventionNames': ['Device: Traditional plastic 2-blade disposable speculum']}, {'type': 'EXPERIMENTAL', 'label': '5-petal Bouquet speculum', 'description': 'Patients assigned to this arm will be evaluated using the 5-petal Bouquet speculum', 'interventionNames': ['Device: Bouquet speculum']}], 'interventions': [{'name': 'Bouquet speculum', 'type': 'DEVICE', 'otherNames': ['884.4520'], 'description': 'Quantitative assessments of visualization of cervix, ease-of-use by the provider, and comfort of the patient', 'armGroupLabels': ['5-petal Bouquet speculum']}, {'name': 'Traditional plastic 2-blade disposable speculum', 'type': 'DEVICE', 'description': 'Quantitative assessments of visualization of cervix, ease-of-use by the provider, and comfort of the patient', 'armGroupLabels': ['Traditional plastic 2-blade disposable speculum']}]}, 'contactsLocationsModule': {'locations': [{'zip': '84790', 'city': 'St. George', 'state': 'Utah', 'country': 'United States', 'facility': 'St. George OB/GYN', 'geoPoint': {'lat': 37.10415, 'lon': -113.58412}}], 'overallOfficials': [{'name': 'James M Small, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rocky Vista University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Unidentified data will be shared when reasonable request is asked to the principal investigator. however this is yet to be decided.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Isain Zapata', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor in Research and Statistics', 'investigatorFullName': 'Isain Zapata', 'investigatorAffiliation': 'Rocky Vista University, LLC'}}}}