Intrauterine Manipulation for Endometrial Cancer

Recruiting in Palo Alto (17 mi)

Overseen byEav Lim, DO

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: WellSpan Health

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial investigates whether using the Vcare® tool during surgery affects the presence of cancer cells in patients with early-stage endometrial cancer. The tool helps surgeons by stabilizing the uterus, aiming for more efficient and safe surgeries.

Eligibility Criteria

This trial is for adults over 18 with diagnosed endometrial cancer who are able to consent and are set for standard surgical treatment without signs of widespread disease in the abdomen. It's not for those whose final pathology isn't endometrial cancer, have spread of cancer within the abdomen, can't undergo surgery, or choose non-surgical management.

Inclusion Criteria

My cancer has not spread within my abdomen.

I am scheduled for surgery for early stage endometrial cancer.

I am 18 or older and can give my consent.

See 1 more

Exclusion Criteria

I cannot undergo surgery for my condition.

I am unable to understand and give consent for treatment.

My cancer has spread within my abdomen.

See 2 more

Treatment Details

Interventions

surgical staging (Procedure)
Vcare® intrauterine manipulator (Procedure)

Trial OverviewThe study investigates if using a Vcare® intrauterine manipulator during surgery increases the chance of finding cancer cells in the abdominal fluid in early stage (FIGO I/II) endometrial cancer patients.

Participant Groups

2Treatment groups

Experimental Treatment

Active Control

Group I: V-care uterine manipulatorExperimental Treatment1 Intervention

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

Group II: Sponge stickActive Control1 Intervention

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