Use of an Intrauterine Manipulator and Its Correlation with Positive Peritoneal Cytology in Early Stage Endometrial Cancers
Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
United States
Pennsylvania
Wellspan Health
RECRUITING
York
Contact Information
Primary
Graham Brown, DO
gbrown5@wellspan.org
717-851-6120
Backup
Eav Lim, DO
elim@wellspan.org
717-851-6120
Time Frame
Start Date: 2020-10-15
Estimated Completion Date: 2027-06-30
Participants
Target number of participants: 350
Treatments
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.
Authors
Related Therapeutic Areas
Sponsors
Leads: WellSpan Health