surgical staging for Endometrial Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Endometrial Cancersurgical staging - Procedure
Eligibility
18+
Female
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Study Summary

This trial will test whether the Vcare® intrauterine manipulator increases the chance of finding cancer cells in the abdomen in women undergoing surgery for early stage endometrial cancer.

Eligible Conditions
  • Endometrial Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 1 Secondary · Reporting Duration: 2 years

2 years
Conversion of positive peritoneal cytology
Recurrence rate

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Sponge stick
1 of 2
V-care uterine manipulator
1 of 2

Active Control

Experimental Treatment

350 Total Participants · 2 Treatment Groups

Primary Treatment: surgical staging · No Placebo Group · N/A

V-care uterine manipulator
Procedure
Experimental Group · 1 Intervention: surgical staging · Intervention Types: Procedure
Sponge stick
Procedure
ActiveComparator Group · 1 Intervention: surgical staging · Intervention Types: Procedure

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 2 years

Who is running the clinical trial?

Graham Brown, DOLead Sponsor
1 Previous Clinical Trials
276 Total Patients Enrolled
Okechukwu Ibeanu, MDPrincipal InvestigatorWellSpan Health
2 Previous Clinical Trials
426 Total Patients Enrolled
1 Trials studying Endometrial Cancer
150 Patients Enrolled for Endometrial Cancer
Eav Lim, DOPrincipal InvestigatorWellSpan Health
2 Previous Clinical Trials
250 Total Patients Enrolled
1 Trials studying Endometrial Cancer
150 Patients Enrolled for Endometrial Cancer

Eligibility Criteria

Age 18+ · Female Participants · 4 Total Inclusion Criteria

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You are able to give informed consent.
References