Recruiting

Pipelle vs. Miltex

Sponsor:

Maimonides Medical Center

Code:

NCT07513493

Conditions

Endometrial Biopsy

Eligibility Criteria

Sex: Female

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Curved Tip Aspirator

Pipelle

Study Details

Brief 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.

Conditions

Endometrial Biopsy

Study ID

NCT07513493

Start date

Jan 2, 2026

Status verified date

Mar, 2026

Completion date

Mar 31, 2028

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 70+

Healthy Volunteers: Accepted

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 Design

Enrollment

124 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

Curved Tip Aspirator

Curved Tip Aspirator; Endomitrial Biopsy Devise

Pipelle

Pipelle; Endomitrial Biopsy Devise

Primary outcome measure

  • Obtaining an adeuate histiopathologic sample [ Time Frame: 30 minutes ]

Central Contacts and Locations

Central contacts

Olivia OB/GYN research manager

718-283-7962osher@maimo.org

Locations

Maimonides Medical Center

Recruiting

Brooklyn, New York, United States, 11219

Contacts

Olivia Sher

718-283-7962osher@maimo.org

More Information

Sponsor

Maimonides Medical Center

Last update posted

Apr 7, 2026

Last verified

Mar, 2026

Keywords

  • Gynecology

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Maimonides Medical Center on 2026-04-07.