Pelvic ExamNCT05254756
"Pilot Study: A Comparison of the Bouquet Speculum and the Traditional 2-Bladed Speculum"
A study testing Bouquet speculum and Traditional plastic 2-blade disposable speculum in people with Pelvic Exam, run by Isain Zapata at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pelvic Exam
- What is being tested?
- Bouquet speculum and Traditional plastic 2-blade disposable speculum
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Mar 2022to 30 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Never had a pelvic exam before
Trial locations and contacts
1 site in 1 country.
About this study
Official title: "A Comparison of the Bouquet Speculum and the Traditional 2-Bladed Speculum"
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.
Read the detailed description
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
- Pelvic Exam
- Being tested
- Bouquet speculum, Traditional plastic 2-blade disposable speculum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bouquet speculumDevice
Also called 884.4520
Quantitative assessments of visualization of cervix, ease-of-use by the provider, and comfort of the patient
Traditional plastic 2-blade disposable speculumDevice
Quantitative assessments of visualization of cervix, ease-of-use by the provider, and comfort of the patient
| Study group | Role | What they receive |
|---|---|---|
| Traditional plastic 2-blade disposable speculum | Active comparator | Patients assigned to this arm will be evaluated using the traditional plastic 2-blade disposable speculum Receives: 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 Receives: Device: Bouquet speculum |
What is being measured
The primary outcome is the main question the study is designed to answer.
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:
- 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 )
- Based on what you anticipated the exam was: (More comfortable, As comfortable/uncomfortable, Less comfortable)
- 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)
- Did the doctor who performed the exam ask you adjust your body position while the speculum was inserted? (Yes, No)
- 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)
Measured: 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.
Measured: 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:
- During the speculum exam, were the lateral walls of the cervix easily visualized upon initial visualization of the cervix? (Yes, No)
- 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)
- 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)
- 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)
Measured: Immediately after the exam
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2022
- Study start21 Mar 2022
- Primary completion30 Oct 2022
- Study completion30 Oct 2022
Why it stopped: The study was stopped because of logistical issues with the sites.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pelvic ExamStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This randomized single-blinded clinical study
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Isain Zapata
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Isain Zapata, Rocky Vista University, LLC
- Investigators
- James M Small, MD, Principal investigator, Rocky Vista University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05254756
- Sponsor's protocol ID
- IRB #2020--0110
- Status last verified
- Nov 2023
- First submitted
- 4 Feb 2022
- Last updated
- 22 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: Unidentified data will be shared when reasonable request is asked to the principal investigator. however this is yet to be decided.
Publications
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
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "A Comparison of the Bouquet Speculum and the Traditional 2-Bladed Speculum"
- ClinicalTrials.gov ID
- NCT05254756
- Acronym / sponsor ID
- IRB #2020--0110
- Conditions
- Pelvic Exam
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was stopped because of logistical issues with the sites.
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Isain ZapataUniversity, hospital or other
- Study start
- 21 Mar 2022 (actual)
- Primary completion
- 30 Oct 2022 (actual)
- Study completion
- 30 Oct 2022 (actual)
- First posted
- 24 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- This randomized single-blinded clinical study
| Arm | Type | Receives |
|---|---|---|
| Traditional plastic 2-blade disposable speculum | Active comparator | Device: Traditional plastic 2-blade disposable speculumPatients assigned to this arm will be evaluated using the traditional plastic 2-blade disposable speculum |
| 5-petal Bouquet speculum | Experimental | Device: Bouquet speculumPatients assigned to this arm will be evaluated using the 5-petal Bouquet speculum |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Never had a pelvic exam before
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bouquet speculumAlso: 884.4520Quantitative assessments of visualization of cervix, ease-of-use by the provider, and comfort of the patient | Device | 5-petal Bouquet speculum |
| Traditional plastic 2-blade disposable speculumQuantitative assessments of visualization of cervix, ease-of-use by the provider, and comfort of the patient | Device | Traditional plastic 2-blade disposable speculum |
Primary outcome
Patient comfort
Time frame: Immediately after the exam
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)
Length of time
Time frame: During the exam
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.
Ease of use
Time frame: Immediately after the exam
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)
Results and safety
The study was stopped early (reason given: The study was stopped because of logistical issues with the sites.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2023.
- BackgroundBouquet 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
- Individual participant dataSharing planned: Undecided. Unidentified data will be shared when reasonable request is asked to the principal investigator. however this is yet to be decided.
Related trials for Pelvic Exam
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Pre-Examination Reflexology for Anxiety and Pain During Pelvic Examination
Anxiety
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James M Small, MD principal investigator
Rocky Vista University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bouquet speculum and Traditional plastic 2-blade disposable speculum in people with Pelvic Exam, run by Isain Zapata at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The study was stopped because of logistical issues with the sites.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient comfort (time frame: Immediately after the exam). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05254756, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2023.