The Use of a Novel Vaginal Speculum for Endometrial Biopsies
Part of paid clinical trials in Englewood, Colorado.
- Sponsor
- Rocky Vista University, LLC
- Study ID
- NCT07217353
- Status
- Enrolling By Invitation
Conditions
Eligibility Criteria
- Sex
- FEMALE
- Age
- 18 Years - 90 Years
- Healthy Volunteers
- Not accepted
Interventions
- Bouquet Speculum — DEVICENovel Bouquet Speculum used for endometrial biopsies
Study Details
The objective of this clinical trial is to determine if a newly-designed and FDA-cleared vaginal speculum (the Bouquet Speculum) will provide better visualization of the cervical os, be easier and more efficient to use, provide more consistent outcomes and decrease the discomfort associated with endometrial biopsy procedures.
Key Dates
- Start date
- Feb 15, 2026
- Status verified
- Jun 2026
- Primary completion
- Sep 30, 2026
- Completion
- Sep 30, 2026
Study Design
- Enrollment
- 100 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- DIAGNOSTIC
Arms
- Experimental: Endometrial biopsies with a new vaginal speculumThe use of a novel, FDA-cleared vaginal speculum for endometrial biopsies
Primary Outcome Measure
Provider visualization of the cervix, ease of use, and accuracy of a new vaginal speculum being used for endometrial biopsies [ Time Frame: Through study completion, an average of 1 year ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Rocky Vista Health Clinic | Englewood | Colorado | 80112 | - |
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