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RECRUITING
NCT07339306
NA

A Novel Fluorescent Ductal Needle for Localization and Sampling of Micro Lesions in Breast Ducts

Sponsor: The Fourth Affiliated Hospital of China Medical University

View on ClinicalTrials.gov

Summary

This prospective, multicenter cohort study investigates the differences in the reliability of rapid pathology compared to postoperative pathology when utilizing a novel fluorescent localization needle equipped with a controllable shedding quantum dot chiral nanofluorescent coating, in contrast to traditional localization techniques for breast duct lesions. The principal objective is to assess the clinical efficacy of this innovative fluorescent localization needle in enabling precise pathological diagnosis of micro lesions in breast ducts.

Official title: A Novel Fluorescent Ductal Needle With Controllable Detachment for Realtime Localization and Sampling of Micro Lesions in Breast Ducts: a Prospective, Multicenter Study

Key Details

Gender

FEMALE

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

300

Start Date

2026-01-01

Completion Date

2026-09-30

Last Updated

2026-01-26

Healthy Volunteers

No

Interventions

DEVICE

novel fluorescent localization marker needle

novel fluorescent localization needle, which features a controllable shedding quantum dot chiral nanofluorescent coating

DEVICE

conventional localization marker needle

conventional localization marker needle, without any coating

Locations (1)

The Fourth Affiliated Hospital of China Medical University

Shenyang, Liaoning, China