The Conventional Pipelle vs the Curved Aspirator Device: a Randomized Controlled Trial
Maimonides Medical Center
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.
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…
Eligibility
- Age range
- 18–95 years
- Sex
- Female
- Healthy volunteers
- Yes
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
Interventions
- DeviceCurved Tip Aspirator
Curved Tip Aspirator; Endomitrial Biopsy Devise
- DevicePipelle
Pipelle; Endomitrial Biopsy Devise
Location
- Maimonides Medical CenterBrooklyn, New York