NCT07513493

Pipelle vs the Curved Aspirator Device

The Conventional Pipelle vs the Curved Aspirator Device: a Randomized Controlled Trial

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 124 (estimated)
• Sponsor: Maimonides Medical Center · Academic / Other
• Sex: Female
• Age: 18 Years – 95 Years
• Healthy volunteers: Accepted

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.

Detailed description

This is a randomized, single-blinded control trial. In this prospective interventional study, patients requiring endometrial sampling will be enrolled from the outpatient clinic of the obstetrics and gynecology department. Patients enrolled in the trial are already scheduled for an endometrial biopsy. In office, endometrial biopsy is a standard of care to access possible disease of the endometrium. Regardless of enrolling in this study, our target patient's population will receive an endometrial biopsy. Current standard is endometrial biopsies are done with both the pipelle and Milltex device based upon availability in the office. These devices are FDA approved for this purpose. Procedural risks include uterine perforation, infection, bleeding or cramping. Risks are the same for both devices. These risks will be discussed when patients sign the procedural consent as regardless of participation in the study patients will receive an endometrial biopsy. The purpose of the consenting them for the study is to consent to randomize and collect data on these patients. PatiUpon enrollment, patients will be randomly assigned to one of two groups: Group A, which will undergo endometrial sampling using the Pipelle device, and Group B, which will undergo sampling using the Miltex device. Patients will be randomized using the NIH randomization tool that correlates patient number with study arm. The study will be single blinded with patient being blinded to the study arm they are assigned. During the procedure, if the initial attempt with the assigned device fails, defined as the inability to insert the sampler through the external or internal os after two attempts (determined by passing the external os \<6cm), the patient will be offered the alternative device as a salvage procedure.

Conditions

• Endometrial Biopsy

Interventions

Type	Name	Description
DEVICE	Curved Tip Aspirator	Curved Tip Aspirator; Endomitrial Biopsy Devise
DEVICE	Pipelle	Pipelle; Endomitrial Biopsy Devise

Timeline

• Start date: 2026-01-02
• Primary completion: 2027-12-31
• Completion: 2028-03-31
• First posted: 2026-04-07
• Last updated: 2026-04-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study