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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorWellSpan Health

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • surgical staging

    Procedure/Surgery

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

Treatment groups

350 Participants
are divided into 2 treatment groups
Group A: V-care uterine manipulatorExperimental treatment 1 intervention
Group B: Sponge stickActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Conversion of positive peritoneal cytology

Intraoperative conversion rate from negative to positive peritoneal cytology will be assessed in each arm

Time frame
2 years

Secondary outcomes

1

Recurrence rate

Endometrial cancer rates at 2 years from surgery will be assessed

Time frame
2 years

Other outcomes

Sponsors and contacts

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