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Artificial Intelligence for the Intra-procedural Assessment of Uterine Artery Embolization

NCT07230444 · tracked via the Priya Life Science Italy tracker
Sponsor
Emanuele Barabino
Phase
Observational
Started
2025-12-01
Last updated
2025-11-19

Condition(s) studied

Uterine Fibroids (UF)

Study summary

Uterine artery embolization is a minimally invasive treatment for symptomatic uterine fibroids, but intra-procedural assessment of embolization adequacy currently relies on subjective angiographic criteria. This study evaluates a proprietary angiographic analysis software (AQ-VERO) that extracts quantitative time-to-density perfusion metrics in real time. The study aims to (1) validate the accuracy and reproducibility of AQ-VERO during uterine artery mebolization, and (2) develop an AI-based decision support system using AQ-VERO-derived metrics to improve objective intra-procedural assessment of treatment endpoints.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
55 Years
Healthy volunteers
No
Inclusion Criteria: * Female patients ≥18 years * Symptomatic uterine fibroids (e.g., bleeding, bulk symptoms, pain) * Underwent UAE as definitive therapy * Availability of baseline clinical/imaging data (for retrospective arm) or ability to provide informed consent (for prospective arm) Exclusion Criteria: * Lack of clinical follow-up * Poor quality or incomplete angiographic images.

Primary outcome measure(s)

  • The primary outcome measure is the AUPRC of the predictive models. — From treatment to the end of the required follow-up (6 months).
    The Area Under the Precision-Recall Curve (AUPRC) will be calculated to evaluate the performance of the AI-based decision support model in identifying clinically relevant embolization endpoints. AUPRC is a threshold-independent metric that summarizes the tradeoff between precision (positive predictive value) and recall (sensitivity) across all decision thresholds. It is particularly suitable for imbalanced datasets, where positive outcome events may be less frequent. Higher AUPRC values indicate better discriminative performance of the model.

Trial sites (1)

FacilityCityRegionStatus
IRCCS OSpedale Policlinico San Martino Genova Genova
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 NCT07230444 on ClinicalTrials.gov ↗ ← All trials in Italy