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Clinical Trials in Italy / NCT07675317
Recruiting Observational

Comparison Between Two Hysteroscopic Biopsy Techniques in the Outpatient Setting for Sampling Hypotrophic or Atrophic Endometrium: 'Rail Biopsy' Versus 'Chip Biopsy'

NCT07675317 · tracked via the Priya Life Science Italy tracker
Phase
Observational
Started
2025-08-04
Last updated
2026-06-30

Condition(s) studied

Atrophic or Hypotrophic Endometrium

Study summary

Hysteroscopic endometrial biopsy is one of the most common procedures in gynecology. For patients with atrophic or hypotrophic endometrium, typical of menopausal women, the "chip biopsy" technique is often preferred as it provides adequate tissue samples for accurate histological examination. Recently, the "rail biopsy" technique has also been adopted at IRCCS AOUBO for biopsies in similar cases. Currently, the choice between these techniques depends largely on operator preference and experience, as there is no strong evidence favoring one over the other in terms of efficacy, safety, or tolerability.

This observational, single-center, cross-sectional, prospective, non-profit study aims to compare the procedure duration of "chip biopsy" versus "rail biopsy" in patients requiring endometrial biopsy of atrophic or hypotrophic endometrium. The study is expected to last approximately 14 months. Approximately 156 patients will be enrolled.

Eligibility

Sex
FEMALE
Min age
48 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: * Age ≥ 48 years and ≤ 75 years * Women with atrophic endometrium, candidates for endometrial biopsy * Informed consent obtained for participation in the study and for the processing of personal data Exclusion Criteria: * Presence of intrauterine fibroids, polyps, and adhesions; * Current or recent (\< 3 months) use of anticoagulant drugs and/or Selective Estrogen Receptor Modulators (SERMs); * Previous confirmed diagnosis of endometrial cancer; * Suspected active pelvic inflammation or history of recent pelvic inflammation (\< 6 months); * Presence of severe stenosis or obliteration of the cervical canal.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
IRCCS Azienda Ospedaliero-Universitaria di Bologna Bologna Bologna Recruiting

More IRCCS Azienda Ospedaliero-Universitaria di Bologna trials in Italy

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07675317 on ClinicalTrials.gov ↗ ← All trials in Italy