Menu
Recruiting NCT07513493

Pipelle vs the Curved Aspirator Device

Phase IV Interventional Endometrial Biopsy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Curved Tip Aspirator, Pipelle.
Who it may be relevant to
Registry conditions: Endometrial Biopsy. Basic parameters: 18 years — 95 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

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.

Interventions

  • Device Curved Tip Aspirator
    Curved Tip Aspirator; Endomitrial Biopsy Devise
  • Device Pipelle
    Pipelle; Endomitrial Biopsy Devise

Primary outcome measures

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

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • Any patient who does not meet the inclusion criteria.
  • Patients with contraindications to endometrial biopsy, including:
  • Pregnancy
  • Acute pelvic inflammatory disease
  • Acute cervical infection
  • Acute vaginal infection
  • Cervical cancer
  • Lack of patient consent

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Maimonides Medical Center — Brooklyn

Identifiers

NCT: NCT07513493 · Pipelle102

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗