Pipelle versus Curved (Miltex) Aspirator for endometrial biopsy
The Conventional Pipelle vs the Curved Aspirator Device: a Randomized Controlled Trial
This test will compare whether the Pipelle or the Miltex curved aspirator gets better tissue samples in people having an in‑office endometrial biopsy.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 124 (estimated) |
| Ages | 18 Years to 95 Years |
| Sex | Female |
| Sponsor | Maimonides Medical Center Academic / other |
| Locations | 1 site (Brooklyn, New York) |
| Trial ID | NCT07513493 on ClinicalTrials.gov |
What this trial studies
This randomized, single‑blind trial enrolls patients already scheduled for an in‑office endometrial biopsy and assigns them to sampling with either a Pipelle or a Miltex curved aspirator. Enrollment occurs in the outpatient OB/GYN clinic at Maimonides, and randomization uses the NIH randomization tool with patients blinded to device assignment. The main outcome is adequacy of endometrial tissue obtained for histopathology, and both FDA‑cleared devices carry the same procedural risks (uterine perforation, infection, bleeding, cramping). All participants receive the standard-of-care biopsy regardless of enrollment, and the study collects data on sample quality and procedural outcomes.
Who should consider this trial
Good fit: Adults scheduled for an endometrial biopsy — including people 18–45 with risk factors for endometrial cancer, people 45–95 with abnormal uterine bleeding, and postmenopausal patients with bleeding or suspected endometrial pathology — are eligible.
Not a fit: People with contraindications to endometrial biopsy (for example pregnancy, acute pelvic/cervical/vaginal infection, cervical cancer), those who decline consent, or those who do not require a biopsy are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the trial could identify which device more reliably yields adequate tissue, reducing the need for repeat procedures and speeding diagnosis.
How similar studies have performed: Both devices are FDA‑cleared and the Pipelle is widely used in practice, but randomized head‑to‑head comparisons are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Brooklyn, New York
- Maimonides Medical Center — Brooklyn, New York, United States (Recruiting)
Study contacts
- Study coordinator: Olivia OB/GYN research manager
- Email: osher@maimo.org
- Phone: 718-283-7962
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.