Recruiting

Observational Study

Sponsor:

Ceek Women's Health, INC

Code:

NCT07846527

Conditions

Adult Females

Eligibility Criteria

Sex: Female

Age: 21 - 65

Healthy Volunteers: Not accepted

Study Details

Brief 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. Investigator perspectives from this mixed-method study will be captured through quantitative and qualitative components.

Conditions

Adult Females

Study ID

NCT07846527

Start date

Sep, 2026

Status verified date

Sep, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 21 - 65

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Subject is pregnant
  • Subject has stated or documented history of vaginal dysplasia or vaginismus

Study Design

Enrollment

500 participants

Anticipated

Interventions and Outcome Measures

Arms

Single Group

Primary outcome measure

  • Vaginal Sidewall Retraction [ Time Frame: Same day as previously scheduled gynecologic exam and/or procedure. ]

Central Contacts and Locations

Central contacts

Tracy Bennett, MD

855-559-2335tbennett@ceekwomenshealth.com

Locations

UCHealth Anschutz

Recruiting

Aurora, Colorado, United States, 80045

Principal Investigator:

Christine Conageski, MD

Denver Health

Recruiting

Denver, Colorado, United States, 80204

Principal Investigator:

Catherine Callinan, MD

Emory University

Recruiting

Atlanta, Georgia, United States, 30322

Principal Investigator:

Lisa Flowers, MD, MPH

More Information

Sponsor

Ceek Women's Health, INC

Last update posted

Sep 29, 2026

Last verified

Sep, 2026

Keywords

  • Iris Study
  • VuSleeve
  • Sheath
  • Vaginal speculum
  • Speculum
  • Loop electrical excision procedure
  • LEEP
  • Colposcopy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-30. This information was provided to ClinicalTrials.gov by Ceek Women's Health, INC on 2026-09-29. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.