Pipelle vs the Curved Aspirator Device

Maimonides Medical Center

Status and phase: Enrolling; Phase 4

Conditions: Endometrial Biopsy

Treatments: Device: Pipelle; Device: Curved Tip Aspirator

Study type: Interventional

Funder types: Other

Identifiers

NCT07513493

Pipelle102

Details and patient eligibility

About

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.

Full 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.

Enrollment: 124 estimated patients

Sex: Female

Ages: 18 to 95 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

124 participants in 2 patient groups

Pipelle

Active Comparator group

Description:

This arm will receive a biopsy using the pipelle device

Treatment:

Device: Pipelle

Curved tip aspirator

Experimental group

Description:

This arm will receive an endometrial biopsy using the curved tip aspirator.

Treatment:

Device: Curved Tip Aspirator