Comparison of a Sheathed Versus Standard Plastic SpeculumNCT01670630
A Comparison of a Sheathed to a Standard Speculum for Visualization of the Cervix
A study testing Sheathed speculum examination and Standard speculum examination in people with Comparison of a Sheathed Versus Standard Plastic Speculum, run by AdventHealth at 1 site in United States.
Trial summary
The purpose of this study is to estimate if a novel sheathed speculum provides improved visualization of the cervix compared to a standard ("non sheathed") speculum, and to estimate if the sheathed speculum causes less discomfort during the examination. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Comparison of a Sheathed Versus Standard Plastic Speculum
- What is being tested?
- Sheathed speculum examination and Standard speculum examination
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2012to Feb 2013
- 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 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Undergoing clinically indicated vaginal speculum examination.
- Subject has had at least 1 prior vaginal deliver > 20 weeks gestational age.
- Able to read and speak English.
Who cannot join
- Active vulvar lesions or conditions (sexually transmitted infections, vestibulodynia, candida, vaginitis, or vulvar dermatologic condition).
- Menopausal or using hormone replacement therapy.
- Genital atrophy.
- Chronic pelvic pain, dyspareunia, or interstitial cystitis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparison of a Novel Sheathed Speculum to a Standard Speculum for Visualization of the Cervix
The purpose of this study is to estimate if a novel sheathed speculum provides improved visualization of the cervix compared to a standard ("non sheathed") speculum, and to estimate if the sheathed speculum causes less discomfort during the examination.
Read the detailed description
This is a randomized trial where physician investigators will perform clinically indicated vaginal speculum examinations using either a sheathed or a standard plastic speculum, to determine which speculum provides the best visualization of the cervix. As a secondary outcome, study participants will record their pain level on a 10-cm visual analogue scale.
- Being tested
- Sheathed speculum examination, Standard speculum examination
- Keywords
- speculum, vagina, cervix, examination
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sheathed speculum examinationProcedure or surgery
Also called speculum, sheath, ClearSpec
Standard speculum examinationProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Sheathed speculum | Active comparator | Investigators will perform a vaginal speculum examination with either a sheathed or a standard ("non sheathed" speculum in a randomized comparison to estimate the degree of cervical visualization and subject pain perception. Receives: Procedure: Sheathed speculum examination |
| Standard speculum examination | Active comparator | Investigators will perform a vaginal speculum examination with either a standard or a sheathed speculum in a randomized comparison to estimate the degree of cervical visualization and subject pain perception. Receives: Procedure: Standard speculum examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of cervix visualized.
To compare the degree of cervical visualization as interpreted by the investigator between the sheathed speculum and the standard plastic disposable speculum.
Measured: During vaginal speculum examination.
Secondary outcomes (1)
Comparison of pain during speculum examination.
To compare the subjects' comfort level between the sheathed and standard speculums when undergoing a vaginal speculum examination, using a patient-reported 10-cm visual analog scale (VAS).
Measured: During speculum examination.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2012 (estimated)
- Study startJul 2012
- Primary completionFeb 2013
- Study completionFeb 2013
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 Comparison of a Sheathed Versus Standard Plastic SpeculumStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 136 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AdventHealth
- Sponsor type
- University, hospital or other
- Collaborators
- MDI Worldwide LLC
- Responsible party
- Principal investigator, D. Ashley Hill, MD, AdventHealth
- Investigators
- David A Hill, M.D., Principal investigator, AdventHealth
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01670630
- Sponsor's protocol ID
- CS201202
- Status last verified
- Feb 2013
- First submitted
- 7 Aug 2012
- Last updated
- 4 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Hill DA, Cacciatore ML, Lamvu G. Sheathed versus standard speculum for visualization of the cervix. Int J Gynaecol Obstet. 2014 May;125(2):116-20. doi: 10.1016/j.ijgo.2013.10.025. Epub 2014 Feb 1.
PubMed 24565103
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of a Novel Sheathed Speculum to a Standard Speculum for Visualization of the Cervix
- ClinicalTrials.gov ID
- NCT01670630
- Acronym / sponsor ID
- CS201202
- Keywords
- speculum, vagina, cervix, examination
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 136 participants (estimated)
- Lead sponsor
- AdventHealthUniversity, hospital or other
- Collaborators
- MDI Worldwide LLC
- Study start
- Jul 2012
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 22 Aug 2012 (estimated)
- 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.
The purpose of this study is to estimate if a novel sheathed speculum provides improved visualization of the cervix compared to a standard ("non sheathed") speculum, and to estimate if the sheathed speculum causes less discomfort during the examination.
Detailed description
This is a randomized trial where physician investigators will perform clinically indicated vaginal speculum examinations using either a sheathed or a standard plastic speculum, to determine which speculum provides the best visualization of the cervix. As a secondary outcome, study participants will record their pain level on a 10-cm visual analogue scale.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sheathed speculum | Active comparator | Procedure: Sheathed speculum examinationInvestigators will perform a vaginal speculum examination with either a sheathed or a standard ("non sheathed" speculum in a randomized comparison to estimate the degree of cervical visualization and subject pain perception. |
| Standard speculum examination | Active comparator | Procedure: Standard speculum examinationInvestigators will perform a vaginal speculum examination with either a standard or a sheathed speculum in a randomized comparison to estimate the degree of cervical visualization and subject pain perception. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Undergoing clinically indicated vaginal speculum examination.
- Subject has had at least 1 prior vaginal deliver > 20 weeks gestational age.
- Able to read and speak English.
Key exclusion criteria (4 listed)
- Active vulvar lesions or conditions (sexually transmitted infections, vestibulodynia, candida, vaginitis, or vulvar dermatologic condition).
- Menopausal or using hormone replacement therapy.
- Genital atrophy.
- Chronic pelvic pain, dyspareunia, or interstitial cystitis.
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 |
|---|---|---|
| Sheathed speculum examinationAlso: speculum, sheath, ClearSpec | Procedure or surgery | Sheathed speculum |
| Standard speculum examination | Procedure or surgery | Standard speculum examination |
Primary outcome
Degree of cervix visualized.
Time frame: During vaginal speculum examination.
To compare the degree of cervical visualization as interpreted by the investigator between the sheathed speculum and the standard plastic disposable speculum.
1 secondary outcome
Comparison of pain during speculum examination.
Time frame: During speculum examination.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2013.
- Derived from this study: PubMed 24565103Hill DA, Cacciatore ML, Lamvu G. Sheathed versus standard speculum for visualization of the cervix. Int J Gynaecol Obstet. 2014 May;125(2):116-20. doi: 10.1016/j.ijgo.2013.10.025. Epub 2014 Feb 1.
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.
David A Hill, M.D. principal investigator
AdventHealth
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sheathed speculum examination and Standard speculum examination in people with Comparison of a Sheathed Versus Standard Plastic Speculum, run by AdventHealth 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 3 inclusion and 4 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: finished, as of the sponsor's last update on 4 Mar 2013. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Degree of cervix visualized. (time frame: During vaginal speculum examination.). 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 NCT01670630, 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 4 Mar 2013.