Pipelle vs the Curved Aspirator Device

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

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.

Study Overview

• Status: Recruiting
• Conditions: Endometrial Biopsy
• Intervention / Treatment: Device: Pipelle; Device: Curved Tip Aspirator

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.

• Study Type: Interventional
• Enrollment (Estimated): 124
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Olivia OB/GYN research manager; Phone Number: 718-283-7962; Email: osher@maimo.org

Study Locations

• United States
  • New York
    • Brooklyn, New York, United States, 11219
      • Recruiting
      • Maimonides Medical Center
      • Contact: Olivia Sher; Phone Number: 718-283-7962; Email: osher@maimo.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Patients <18- 45 years with risk factors for endometrial cancer requiring endometrial biopsy.
2. Patients ≥ 45 -95 years with abnormal uterine bleeding.
3. Postmenopausal patients with bleeding or suspected endometrial pathology

Exclusion Criteria:

1. Any patient who does not meet the inclusion criteria.

2. Patients with contraindications to endometrial biopsy, including:

   • Pregnancy
   • Acute pelvic inflammatory disease
   • Acute cervical infection
   • Acute vaginal infection
   • Cervical cancer
   • Lack of patient consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Pipelle; This arm will receive a biopsy using the pipelle device	Device: Pipelle; Pipelle; Endomitrial Biopsy Devise
Experimental: Curved tip aspirator; This arm will receive an endometrial biopsy using the curved tip aspirator.	Device: Curved Tip Aspirator; Curved Tip Aspirator; Endomitrial Biopsy Devise

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Obtaining an adeuate histiopathologic sample	defined as the inability to insert the sampler through the external or internal os after two attempts (determined by passing the external os <6cm)	30 minutes

Collaborators and Investigators

• Sponsor: Maimonides Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): January 2, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): March 31, 2028

Study Registration Dates

• First Submitted: June 24, 2025
• First Submitted That Met QC Criteria: March 30, 2026
• First Posted (Actual): April 7, 2026

Study Record Updates

• Last Update Posted (Actual): April 7, 2026
• Last Update Submitted That Met QC Criteria: March 30, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Gynecology
• Other Study ID Numbers: Pipelle102

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Our consents opted for data to only be shared for this study.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No