Use of an Intrauterine Manipulator and Its Correlation with Positive Peritoneal Cytology in Early Stage Endometrial Cancers

Part of paid clinical trials in York, Pennsylvania.

Sponsor
WellSpan Health
Study ID
NCT04570553
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Oct 15, 2020
Status verified
Apr 2024
Primary completion
Apr 30, 2026
Completion
Jun 30, 2027

Study Design

Enrollment
350 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC

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.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Wellspan HealthYorkPennsylvania17403
Graham Brown, DO
[email protected]
717-851-6120

Find similar trials in York, PA

By condition
Endometrial cancer
By specialty
OncologyGynecologic oncologyWomen's health
By research site
Wellspan Health· York, PA

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