The Conventional Pipelle vs the Curved Aspirator Device: a Randomized Controlled Trial
Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Phase 4
SUMMARY
The primary aim of this study is to rigorously compare the efficacy of two commonly used endometrial sampling devices, the Pipelle and the Miltex, these devices are standard of care at Maimonides. This primary objective is critical, as the ability to accurately reach the uterine cavity is fundamental to obtaining adequate samples for histopathological evaluation, which is crucial for diagnosing endometrial cancer and other uterine pathologies.
Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 95
Healthy Volunteers: t
View:
• Patients \<18- 45 years with risk factors for endometrial cancer requiring endometrial biopsy.
• Patients ≥ 45 -95 years with abnormal uterine bleeding.
• Postmenopausal patients with bleeding or suspected endometrial pathology
Locations
United States
New York
Maimonides Medical Center
RECRUITING
Brooklyn
Contact Information
Primary
Olivia OB/GYN research manager
osher@maimo.org
718-283-7962
Time Frame
Start Date: 2026-01-02
Estimated Completion Date: 2028-03-31
Participants
Target number of participants: 124
Treatments
Active_comparator: Pipelle
This arm will receive a biopsy using the pipelle device
Experimental: Curved tip aspirator
This arm will receive an endometrial biopsy using the curved tip aspirator.
Related Therapeutic Areas
Sponsors
Leads: Maimonides Medical Center