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

NCT ID: NCT05254756

Last Updated: 2023-11-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-21

Study Completion Date

2022-10-30

Brief Summary

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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.

Detailed Description

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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.

The 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.

Conditions

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Pelvic Exam

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This randomized single-blinded clinical study
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Caregivers
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.

Study Groups

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Traditional plastic 2-blade disposable speculum

Patients assigned to this arm will be evaluated using the traditional plastic 2-blade disposable speculum

Group Type ACTIVE_COMPARATOR

Traditional plastic 2-blade disposable speculum

Intervention Type DEVICE

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

5-petal Bouquet speculum

Patients assigned to this arm will be evaluated using the 5-petal Bouquet speculum

Group Type EXPERIMENTAL

Bouquet speculum

Intervention Type DEVICE

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

Interventions

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Bouquet speculum

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

Intervention Type DEVICE

Traditional plastic 2-blade disposable speculum

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

Intervention Type DEVICE

Other Intervention Names

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884.4520

Eligibility Criteria

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Inclusion Criteria

* Female patients that require a pelvic exam.
* 18 years of age or older
* Having had at least one previous pelvic exam with the traditional speculum
* Consent to participate in the study

Exclusion Criteria

\- Never had a pelvic exam before
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Isain Zapata

OTHER

Sponsor Role lead

Responsible Party

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Isain Zapata

Assistant Professor in Research and Statistics

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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James M Small, MD

Role: PRINCIPAL_INVESTIGATOR

Rocky Vista University

Locations

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St. George OB/GYN

St. George, Utah, United States

Site Status

Countries

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United States

References

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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

Reference Type BACKGROUND

Other Identifiers

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IRB #2020--0110

Identifier Type: -

Identifier Source: org_study_id