HealthyNCT00595166
Using a Sheathed Speculum to Visualize and Access the Cervix in Women With Excessive Vaginal Tissue
An observational study of Healthy, run by University of South Florida at 1 site in United States.
Trial summary
This new invention addresses the inadequate and incomplete visualization of the cervix in patients with excessive vaginal tissue. In general these patients are obese, or are multiparous with a history of multiple vaginal deliveries. Read more about this study
- Who is it for?
- Ages 18 to 64 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Vaginal Speculum Sheath
- Type of treatment
- Medical device
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2007to Mar 2013
- Phase
- Observational
- 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 64 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Women who were unable to have a speculum exam completed due to collapse of vaginal tissues that occludes visibility of the cervix.
Who may be able to join
- The following criteria must be present for randomization into the study:
- Age 18 to 64.
- BMI greater than 30.
- Collapsing vaginal tissue preventing the visualization of the cervix (meeting this criterion in the absence of a BMI >30 would also qualify the patient for the study).
- Able to provide written informed consent
Who cannot join
- The following criteria would exclude patients from randomization into the study:
- Patients unwilling to participate in the study or provide consent.
- Presence of dyspareunia (due to chronic pelvic pain, pelvic floor dysfunction, atrophic vaginitis, or any other etiology).
- Presence of other significant pelvic pain syndromes (interstitial cystitis, endometriosis).
- Presence of active genital herpes.
- Presence of significant condyloma acuminata (may be an investigator decision).
- Any other patient deemed inappropriate for the study by the consenting or examining investigator.
Trial locations and contacts
1 site in 1 country.
United States1 site
USF South Tampa Center for Advanced Healthcare
Tampa, Florida, 33606
About this study
This new invention addresses the inadequate and incomplete visualization of the cervix in patients with excessive vaginal tissue. In general these patients are obese, or are multiparous with a history of multiple vaginal deliveries.
A vaginal speculum is a vital medical instrument that allows a health care provider to visualize the interior aspects of the vagina, as well as the distal portion of the uterus, the cervix. It is composed of 2 blades assembled together and held by a handle. The blades and the handle form a 90 degree-angle. As the user holds the handle, a lever attached to the top blade allows it to open away from the inferior blade.
Read more
When the instrument is inserted into the vagina, the two blades are separated in order to keep the anterior and posterior vaginal walls apart. In that position, the cervix and the walls of the vagina can be seen if the patient does not have an excess of loose vaginal tissue. However, in patients with excessive tissue, the sidewalls of the vagina simply collapse toward the midline between the blades because of the fact that no part of the speculum is in direct contact with the lateral walls of the vagina. This collapse prevents the complete and crucial visualization of the cervix for purposes of cervical cultures, pap smears, visual assessment of ruptured membranes, visual assessment of the degree of dilation, biopsies, and other procedures requiring access to the cervix or the uterus.
When clinicians face this dilemma, they may try the largest speculum available, and will open it as wide as possible in order to keep the lateral walls apart. Most often, they have to improvise by cutting the tip of a condom, or the thumb off a glove, or they use a sterile lateral-wall retractor. These other creative solutions can take several minutes of precious times and may still result in an inadequate visualization and suboptimal access.
A vaginal speculum sheath for retaining vaginal tissue in a lateral direction conforms to a pair of blades that are movable between an opened position and a closed position. The blades in the closed position are adapted for insertion into a vagina, and in the open position, they allow dilating the vagina in order to provide access to the cervix.
This new design includes a flexible, transparent polyurethane sleeve structure that extends between the blades when the speculum is opened. The stretched sheath is adapted to retain the lateral walls of the vagina in the open position. The elastic sleeve is designed to remain in a collapsed configuration when the blades are in a closed position to avoid interfering with insertion or withdrawal of the speculum [Reference: U.S. patent 6432048 (2002-8-13)]. Polyurethane material is FDA approved for vaginal use.
The purpose of this study is to compare standard of care speculum vs. sheathed speculum in the examination of patients with collapsing vaginal sidewalls during a gynecological speculum exam.
The primary hypothesis testing for this study will be to compare the standard of care speculum exam to a sheathed speculum exam in a prospective, randomized clinical trial.
- Conditions
- Healthy
- Being tested
- Vaginal Speculum Sheath
- Keywords
- Women with excessive vaginal tissue that obstruct the examiner's view of the cervix during a vaginal speculum examination
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vaginal Speculum SheathDevice
Patients received the sheathed speculum exam: The clinician will begin to place the sheath onto the speculum. The sheath is attached to a thin piece of cardboard. The proximal end of the cardboard is placed between the speculum blades and is pushed toward the speculum handle. The blades of the speculum are simultaneously guided to enter the 2 pockets of the sleeve, like fingers going into a glove. The speculum exam will then be completed according to usual procedures. In the event the sheathed speculum exam is unsatisfactory the clinician will do standard of care (the clinician's usual routine at the bedside).
| Study group | Role | What they receive |
|---|---|---|
| B | Speculum Sheath group. Participants all received the speculum sheath. Receives: Device: Vaginal Speculum Sheath |
What is being measured
The primary outcome is the main question the study is designed to answer.
The main objective of the study is to assess the effectiveness of a sheathed speculum compared to standard of care procedures in providing adequate visualization and access to the cervix in patients with excessive vaginal tissue.
Measured: Once the cervix is visualized, the timing of the procedure will stop.
Secondary outcomes (1)
The two speculum examination procedures will also be timed from the moment of randomization to the visualization of the cervical os.
Measured: Once the cervix is visualized, the timing of the procedure will stop.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2008 (estimated)
- Study startJun 2007
- Primary completionMar 2013
- Study completionMar 2013
Why it stopped: Design changed to observational, not RCT. PI left USF; study closed.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of South Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rony Francois, MD, PhD, Principal investigator, University of South Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00595166
- Sponsor's protocol ID
- SpecSheath
- Status last verified
- Apr 2016
- First submitted
- 4 Jan 2008
- Last updated
- 6 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using a Sheathed Speculum to Visualize and Access the Cervix in Women With Excessive Vaginal Tissue
- ClinicalTrials.gov ID
- NCT00595166
- Acronym / sponsor ID
- SpecSheath
- Conditions
- Healthy
- Keywords
- Women with excessive vaginal tissue that obstruct the examiner's view of the cervix during a vaginal speculum examination
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Design changed to observational, not RCT. PI left USF; study closed.
- Enrolment
- 38 participants (actual)
- Lead sponsor
- University of South FloridaUniversity, hospital or other
- Study start
- Jun 2007
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 16 Jan 2008 (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.
This new invention addresses the inadequate and incomplete visualization of the cervix in patients with excessive vaginal tissue. In general these patients are obese, or are multiparous with a history of multiple vaginal deliveries.
A vaginal speculum is a vital medical instrument that allows a health care provider to visualize the interior aspects of the vagina, as well as the distal portion of the uterus, the cervix. It is composed of 2 blades assembled together and held by a handle. The blades and the handle form a 90 degree-angle. As the user holds the handle, a lever attached to the top blade allows it to open away from the inferior blade.
When the instrument is inserted into the vagina, the two blades are separated in order to keep the anterior and posterior vaginal walls apart. In that position, the cervix and the walls of the vagina can be seen if the patient does not have an excess of loose vaginal tissue. However, in patients with excessive tissue, the sidewalls of the vagina simply collapse toward the midline between the blades because of the fact that no part of the speculum is in direct contact with the lateral walls of the vagina. This collapse prevents the complete and crucial visualization of the cervix for purposes of cervical cultures, pap smears, visual assessment of ruptured membranes, visual assessment of the degree of dilation, biopsies, and other procedures requiring access to the cervix or the uterus.
When clinicians face this dilemma, they may try the largest speculum available, and will open it as wide as possible in order to keep the lateral walls apart. Most often, they have to improvise by cutting the tip of a condom, or the thumb off a glove, or they use a sterile lateral-wall retractor. These other creative solutions can take several minutes of precious times and may still result in an inadequate visualization and suboptimal access.
A vaginal speculum sheath for retaining vaginal tissue in a lateral direction conforms to a pair of blades that are movable between an opened position and a closed position. The blades in the closed position are adapted for insertion into a vagina, and in the open position, they allow dilating the vagina in order to provide access to the cervix.
This new design includes a flexible, transparent polyurethane sleeve structure that extends between the blades when the speculum is opened. The stretched sheath is adapted to retain the lateral walls of the vagina in the open position. The elastic sleeve is designed to remain in a collapsed configuration when the blades are in a closed position to avoid interfering with insertion or withdrawal of the speculum [Reference: U.S. patent 6432048 (2002-8-13)]. Polyurethane material is FDA approved for vaginal use.
The purpose of this study is to compare standard of care speculum vs. sheathed speculum in the examination of patients with collapsing vaginal sidewalls during a gynecological speculum exam.
The primary hypothesis testing for this study will be to compare the standard of care speculum exam to a sheathed speculum exam in a prospective, randomized clinical trial.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| B | – | Device: Vaginal Speculum SheathSpeculum Sheath group. Participants all received the speculum sheath. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Women who were unable to have a speculum exam completed due to collapse of vaginal tissues that occludes visibility of the cervix.
Key inclusion criteria (5 listed)
- Age 18 to 64.
- BMI greater than 30.
- Collapsing vaginal tissue preventing the visualization of the cervix (meeting this criterion in the absence of a BMI >30 would also qualify the patient for the study).
- Able to provide written informed consent
Key exclusion criteria (7 listed)
- Patients unwilling to participate in the study or provide consent.
- Presence of dyspareunia (due to chronic pelvic pain, pelvic floor dysfunction, atrophic vaginitis, or any other etiology).
- Presence of other significant pelvic pain syndromes (interstitial cystitis, endometriosis).
- Presence of active genital herpes.
- Presence of significant condyloma acuminata (may be an investigator decision).
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 |
|---|---|---|
| Vaginal Speculum SheathPatients received the sheathed speculum exam: The clinician will begin to place the sheath onto the speculum. The sheath is attached to a thin piece of cardboard. The proximal end of the cardboard is placed between the speculum blades and is pushed toward the speculum handle. The blades of the speculum are simultaneously guided to enter the 2 pockets of the sleeve, like fingers going into a glove. The speculum exam will then be completed according to usual procedures. In the event the sheathed speculum exam is unsatisfactory the clinician will do standard of care (the clinician's usual routine at the bedside). | Device | B |
Primary outcome
The main objective of the study is to assess the effectiveness of a sheathed speculum compared to standard of care procedures in providing adequate visualization and access to the cervix in patients with excessive vaginal tissue.
Time frame: Once the cervix is visualized, the timing of the procedure will stop.
1 secondary outcome
The two speculum examination procedures will also be timed from the moment of randomization to the visualization of the cervical os.
Time frame: Once the cervix is visualized, the timing of the procedure will stop.
Results and safety
The study was stopped early (reason given: Design changed to observational, not RCT. PI left USF; study closed.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2016.
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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.
Rony Francois, MD, PhD principal investigator
University of South Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by University of South Florida 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 5 inclusion and 7 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 6 Apr 2016. 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: Design changed to observational, not RCT. PI left USF; study closed.). 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?
The main objective of the study is to assess the effectiveness of a sheathed speculum compared to standard of care procedures in providing adequate visualization and access to the cervix in patients with excessive vaginal tissue. (time frame: Once the cervix is visualized, the timing of the procedure will stop.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Apr 2016.