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

NCT05254756 | Terminated FDA Device

• 1 other identifier: IRB #2020--0110
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (3)

• Patient comfort

  Find the difference in the level of patient comfort during a vaginal speculum exam between the traditional 2-blade plastic disposable speculum and the 5-petal Bouquet speculum. Assessed with a questionnaire answered by the patient: 1. What was the level of comfort with this Pap smear compared to other speculum exams you have had? (More comfortable, Same level of comfort/discomfort, Less comfortable ) 2. Based on what you anticipated the exam was: (More comfortable, As comfortable/uncomfortable, Less comfortable) 3. On a scale from 0 to 10, what is the highest level of pain you experienced during the Pap smear/speculum exam? (10 being the worst pain you have ever experienced, and 0 being no pain) 4. Did the doctor who performed the exam ask you adjust your body position while the speculum was inserted? (Yes, No) 5. What is your estimation of how long the speculum was inserted? (0-30 seconds, 30-60 seconds, 1-2 minutes, 2-3 minutes, \>3 minutes)

  Immediately after the exam

• Length of time

  Find the difference in the length of time that the Bouquet speculum is inserted during a Pap smear compared to the traditional 2-blade speculum. The time the speculum is inserted is recorded for every interactions.

  During the exam

• Ease of use

  Find the difference in ease of use for the provider between the traditional 2-blade plastic disposable speculum and the 5-petal Bouquet speculum. Assessed with a questionnaire answered by the provider: 1. During the speculum exam, were the lateral walls of the cervix easily visualized upon initial visualization of the cervix? (Yes, No) 2. What is your estimate of how long the speculum was inserted? (0-30 seconds, 30-60 seconds, 1-2 minutes, 2-3 minutes, \>3 minutes) 3. While the speculum was inserted, was the patient asked to adjust body position in order to gain a better view of the cervix? (Yes, No) 4. Were special maneuvers performed in order to better visualize the cervix? (e.g. use a different size/type of speculum, apply a condom over the speculum to view the lateral walls, re-insert the speculum, etc.)? (Yes, No)

  Immediately after the exam

Study Arms (2)

Traditional plastic 2-blade disposable speculum

ACTIVE COMPARATOR

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

Device: Traditional plastic 2-blade disposable speculum

5-petal Bouquet speculum

EXPERIMENTAL

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

Device: Bouquet speculum

Interventions

Bouquet speculum DEVICE

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

Also known as: 884.4520

5-petal Bouquet speculum

Traditional plastic 2-blade disposable speculum DEVICE

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

Traditional plastic 2-blade disposable speculum

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• \- Never had a pelvic exam before

Sponsors & Collaborators

• Isain Zapata: lead

Study Sites (1)

St. George OB/GYN

St. George, Utah, 84790, United States

Location

Related Publications (1)

• 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

  BACKGROUND

Study Officials

• James M Small, MD

  Rocky Vista University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor in Research and Statistics

Model Details: This randomized single-blinded clinical study

Study Record Dates

• First Submitted: February 4, 2022
• First Posted: February 24, 2022
• Study Start: March 21, 2022
• Primary Completion: October 30, 2022
• Study Completion: October 30, 2022
• Last Updated: November 22, 2023

Record last verified: 2023-11

Locations

US (1)