Recruiting

Vcare®

Sponsor:

WellSpan Health

Code:

NCT04570553

Conditions

Endometrial Cancer

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

surgical staging

Study Details

Brief summary:

This study aims to answer whether use of a Vcare® intrauterine manipulator leads to an increased incidence of positive peritoneal cytology in patients undergoing surgical management of early stage (FIGO stage I/II) endometrial cancer.

Conditions

Endometrial Cancer

Study ID

NCT04570553

Start date

Oct 15, 2020

Status verified date

Apr, 2024

Completion date

Jun 30, 2027

Anticipated

Primary completion date

Apr 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Subjects age 18 or older able to give informed consent
  • Biopsy diagnosed endometrial cancer (including endometrioid, serous, mucinous and clear cell histologies)
  • Planned standard of care surgical management of early stage endometrial cancer
  • No clinical evidence of disseminated intraperitoneal disease

Exclusion Criteria:

  • Final pathology does not reflect diagnosis of endometrial cancer (including endometrioid, serous, mucinous, and clear cell histology)
  • Evidence of disseminated intraperitoneal disease
  • Subject is not a surgical candidate
  • Subject elects for fertility sparing or non-operative management
  • Subject is unable to provide informed consent

Study Design

Enrollment

350 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: V-care uterine manipulator

Patients in the V-care uterine manipulator arm will undergo standard staging surgery utilizing a V-care uterine manipulator in the standard fashion

active comparator: Sponge stick

Patients in the sponge stick arm will undergo standard staging surgery utilizing a non-invasive sponge stick for cervical delineation.

Interventions

surgical staging

Patients will undergo standard surgical staging for endometrial cancer utilizing either a V-care uterine manipulator or sponge stick

Primary outcome measure

  • Conversion of positive peritoneal cytology [ Time Frame: 2 years ]

Central Contacts and Locations

Central contacts

Graham Brown, DO

717-851-6120gbrown5@wellspan.org

Eav Lim, DO

717-851-6120elim@wellspan.org

Locations

Wellspan Health

Recruiting

York, Pennsylvania, United States, 17403

Contacts

Graham Brown, DO

717-851-6120gbrown5@wellspan.org

More Information

Sponsor

WellSpan Health

Last update posted

Mar 28, 2025

Last verified

Apr, 2024

Keywords

  • endometrial cancer
  • peritoneal cytology

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by WellSpan Health on 2025-03-28.