Adult FemalesNCT07846527
Vaginal Wall Retraction Using VuSleeve
An observational study of Adult Females, run by Ceek Women's Health, INC at 3 sites in United States.
Trial summary
This is a post-market, observational, non-interventional, single group/cohort study in which participants already have a scheduled gynecological exam and/or procedure. The goal of this study is to obtain investigator perspectives on using VuSleeve for routine gynecological care. Read more about this study
- Who is it for?
- Ages 21 to 65 years, women only
- Conditions the study is for
- Adult Females
- How many people
- 500 participants
- Where
- 3 sitesUnited States
- Study dates
- Sep 2026to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 21 to 65 years
- Women only
- Adult, Older adult
Study population: Adult female subjects seeking gynecological care at participating study sites.
Who may be able to join
- Subject was assigned female at birth
- Subject is 21 - 65 years of age, inclusive, at the time of exam or procedure
- Subject is undergoing a gynecological exam and/or procedure
- Subject has undergone one or more prior gynecological exams
Who cannot join
- Subject is pregnant
- Subject has stated or documented history of vaginal dysplasia or vaginismus
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
Emory University
Atlanta, Georgia, 30322
Lisa Flowers, MD, MPH
Nadi Kaonga, MD
- Recruiting
UCHealth Anschutz
Aurora, Colorado, 80045
Christine Conageski, MD
- Recruiting
Denver Health
Denver, Colorado, 80204
Catherine Callinan, MD
About this study
Official title: Vaginal Wall Retraction in Gynecologic Exams and Procedures Using VuSleeve (Iris Study)
This is a post-market, observational, non-interventional, single group/cohort study in which participants already have a scheduled gynecological exam and/or procedure. The goal of this study is to obtain investigator perspectives on using VuSleeve for routine gynecological care. Investigator perspectives from this mixed-method study will be captured through quantitative and qualitative components.
- Conditions
- Adult Females
- Keywords
- Iris Study, VuSleeve, Sheath, Vaginal speculum, Speculum, Loop electrical excision procedure, LEEP, Colposcopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Single Group | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vaginal Sidewall Retraction
Percent of vaginal sidewall tissue retracted during gynecological exams and procedures using the VuSleeve with a vaginal speculum.
Measured: Same day as previously scheduled gynecologic exam and/or procedure.
Secondary outcomes (3)
Access to the Cervix
Number of subjects that the cervix was able to be accessed.
Measured: Same day as previously scheduled gynecologic exam and/or procedure.
Visualization of the Cervix
Percent of the cervix that was able to be viewed.
Measured: Same day as previously scheduled gynecologic exam and/or procedure.
Vaginal Sidewall Protection
Percent protection of vaginal sidewalls from accidental cutting/burning during LEEP.
Measured: Same day as previously scheduled gynecologic exam and/or procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2026
- Study startSep 2026 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adult FemalesStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ceek Women's Health, INC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07846527
- Sponsor's protocol ID
- 2025P013955
- Status last verified
- Sep 2026
- First submitted
- 3 Sep 2026
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vaginal Wall Retraction in Gynecologic Exams and Procedures Using VuSleeve (Iris Study)
- ClinicalTrials.gov ID
- NCT07846527
- Acronym / sponsor ID
- 2025P013955
- Conditions
- Adult Females
- Keywords
- Iris Study, VuSleeve, Sheath, Vaginal speculum, Speculum, Loop electrical excision procedure, LEEP, Colposcopy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Ceek Women's Health, INCIndustry (pharma, biotech, devices)
- Study start
- Sep 2026 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 29 Sep 2026 (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 is a post-market, observational, non-interventional, single group/cohort study in which participants already have a scheduled gynecological exam and/or procedure. The goal of this study is to obtain investigator perspectives on using VuSleeve for routine gynecological care. Investigator perspectives from this mixed-method study will be captured through quantitative and qualitative components.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Group | – | – |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- Adult female subjects seeking gynecological care at participating study sites.
Key inclusion criteria (4 listed)
- Subject was assigned female at birth
- Subject is 21 - 65 years of age, inclusive, at the time of exam or procedure
- Subject is undergoing a gynecological exam and/or procedure
- Subject has undergone one or more prior gynecological exams
Key exclusion criteria (2 listed)
- Subject is pregnant
- Subject has stated or documented history of vaginal dysplasia or vaginismus
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Vaginal Sidewall Retraction
Time frame: Same day as previously scheduled gynecologic exam and/or procedure.
Percent of vaginal sidewall tissue retracted during gynecological exams and procedures using the VuSleeve with a vaginal speculum.
3 secondary outcomes
Access to the Cervix
Time frame: Same day as previously scheduled gynecologic exam and/or procedure.
Visualization of the Cervix
Time frame: Same day as previously scheduled gynecologic exam and/or procedure.
Vaginal Sidewall Protection
Time frame: Same day as previously scheduled gynecologic exam and/or procedure.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
- Individual participant dataSharing planned: No
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adult Females, run by Ceek Women's Health, INC at 3 sites 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 2 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: looking for participants now, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tracy Bennett, MD (855-559-2335, tbennett@ceekwomenshealth.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vaginal Sidewall Retraction (time frame: Same day as previously scheduled gynecologic exam and/or procedure.). 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 29 Sep 2026.