Pipelle versus Curved (Miltex) Aspirator for endometrial biopsy
Official title: The Conventional Pipelle vs the Curved Aspirator Device: a Randomized Controlled Trial
Run by Maimonides Medical Center · NCT07513493 · Data updated 2026-11-12
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 |
| Ages | 18 Years to 95 Years |
| Sex | Women only |
| Enrollment | 124 (estimated) |
| Sponsor | Maimonides Medical Center Academic / other |
| Locations | 1 site (Brooklyn, New York) |
| Status | Recruiting |
| Started | January 2, 2026 |
| Main results expected | December 31, 2027 |
| Study ends | March 31, 2028 |
| Registry record updated | September 17, 2026 |
| Trial ID | NCT07513493 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: Both devices are FDA‑cleared and the Pipelle is widely used in practice, but randomized head‑to‑head comparisons are limited.
Who can join: the full rules
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 it's running
-
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
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.