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 — DEVICE
    Novel 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 speculum
    The 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)

FacilityCityStateZIPSite coordinators
Rocky Vista Health ClinicEnglewoodColorado80112-

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