RecruitingPhase 4NCT07513493

Pipelle vs the Curved Aspirator Device

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


Sponsor

Maimonides Medical Center

Enrollment

124 participants

Start Date

Jan 2, 2026

Study Type

INTERVENTIONAL

Conditions

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

Sex: FEMALEMin Age: 18 YearsMax Age: 95 Years

Inclusion Criteria10

  • 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
  • Patients with contraindications to endometrial biopsy, including:
  • Pregnancy
  • Acute pelvic inflammatory disease
  • Acute cervical infection
  • Acute vaginal infection
  • Cervical cancer
  • Lack of patient consent

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Interventions

DEVICECurved Tip Aspirator

Curved Tip Aspirator; Endomitrial Biopsy Devise

DEVICEPipelle

Pipelle; Endomitrial Biopsy Devise


Locations(1)

Maimonides Medical Center

Brooklyn, New York, United States

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NCT07513493


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