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Recruiting NCT04570553

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

Trial Parameters

Condition Endometrial Cancer
Sponsor WellSpan Health
Study Type INTERVENTIONAL
Phase N/A
Enrollment 350
Sex FEMALE
Min Age 18 Years
Max Age N/A
Start Date 2020-10-15
Completion 2026-04-30
Interventions
surgical staging

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.

Eligibility Criteria

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

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