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"Pilot Study: A Comparison of the Bouquet Speculum and the Traditional 2-Bladed Speculum"

NCT05254756 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2023-11-22

No results posted yet for this study

Summary

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.

Conditions

  • Pelvic Exam

Interventions

DEVICE

Bouquet speculum

Quantitative assessments of visualization of cervix, ease-of-use by the provider, and comfort of the patient

DEVICE

Traditional plastic 2-blade disposable speculum

Quantitative assessments of visualization of cervix, ease-of-use by the provider, and comfort of the patient

Sponsors & Collaborators

  • Isain Zapata

    lead OTHER

Principal Investigators

  • James M Small, MD · Rocky Vista University

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-03-21
Primary Completion
2022-10-30
Completion
2022-10-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05254756 on ClinicalTrials.gov