Recruiting

Uterine Lavage

Sponsor:

Stanford University

Code:

NCT07044505

Conditions

Gynecologic Cancer

Gynecologic Disease

Gynecological Surgery

Uterine Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Uterine Lavage

Study Details

Brief summary:

This study is a designed as a to test the clinical and technical feasibility of using this novel uterine lavage collection catheter to collected UL samples from up to 50 individuals undergoing gynecologic surgery and to describe the cellular composition of these samples. In order to do this, it is a prospective consecutively-enrolled cohort of 50 participants, all of who will receive the intervention of uterine lavage collection.

Conditions

Gynecologic Cancer

Gynecologic Disease

Gynecological Surgery

Uterine Cancer

Study ID

NCT07044505

Start date

Sep 19, 2025

Status verified date

Nov, 2025

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Undergoing gynecologic surgery with Stanford Healthcare
  • Intact uterus and cervix
  • At least one intact fallopian tube and ovary (on the same side)
  • Aged 18 years or older
  • Ability to understand and the willingness to provide written informed consent.

Exclusion Criteria:

  • Known endometrial or cervical cancer or endometrial or cervical intraepithelial neoplasia
  • Status post bilateral salpingectomy or tubal ligation
  • Lack of consenting capacity
  • Positive preoperative pregnancy test
  • Active uterine bleeding (i.e. menses, etc.)
  • Intrauterine device in place
  • Non-English speaking (requires interpretor)

Study Design

Enrollment

50 participants

Anticipated

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Single Group

Participants undergoing gynecologic surgery who agree to uterine lavage collection intraoperatively for molecular and cellular analysis.

Interventions

Uterine Lavage

Saline is introduced into the uterine cavity and retrieved during surgery to collect cells and fluid for downstream molecular and cellular analyses.

Primary outcome measure

  • Characterization of cellular composition in uterine lavage fluid [ Time Frame: At time of gynecologic surgery ]

Central Contacts and Locations

Central contacts

Locations

Stanford University

Recruiting

Palo Alto, California, United States, 94304

Contacts

Principal Investigator:

James Ford, MD

More Information

Sponsor

Stanford University

Last update posted

Nov 5, 2025

Last verified

Nov, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Stanford University on 2025-11-05.