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Molecular and Cellular Profiling of Uterine Lavage Collected During Gynecologic Surgery

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Stanford University

Status

Enrolling

Conditions

Uterine Cancer
Gynecological Surgery
Gynecologic Cancer
Gynecologic Disease

Treatments

Procedure: Uterine Lavage

Study type

Interventional

Funder types

Other

Identifiers

NCT07044505
IRB-77882

Details and patient eligibility

About

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.

Enrollment

50 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Basic Science

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

50 participants in 1 patient group

Single Group
Experimental group
Description:
Participants undergoing gynecologic surgery who agree to uterine lavage collection intraoperatively for molecular and cellular analysis.
Treatment:
Procedure: Uterine Lavage

Trial contacts and locations

1

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Central trial contact

Rozelle Laquindanum

Data sourced from clinicaltrials.gov

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