The Use of a Novel Vaginal Speculum for Endometrial Biopsies
NCT07217353 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100
Last updated 2025-10-15
Summary
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.
Conditions
Interventions
- DEVICE
-
Bouquet Speculum
Novel Bouquet Speculum used for endometrial biopsies
Sponsors & Collaborators
-
Rocky Vista University, LLC
lead OTHER
Principal Investigators
-
Laura Dement, MA · Rocky Vista University
Study Design
- Allocation
- NA
- Purpose
- DIAGNOSTIC
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 90 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-10-15
- Primary Completion
- 2026-03-31
- Completion
- 2026-06-15
- FDA Device
- Yes
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