RecruitingNot ApplicableNCT07339306

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

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


Sponsor

The Fourth Affiliated Hospital of China Medical University

Enrollment

300 participants

Start Date

Jan 1, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new type of fluorescent needle for use during breast duct surgery. The needle is designed to help surgeons precisely locate and sample tiny lesions deep inside breast ducts that are otherwise difficult to find, potentially improving how early breast conditions are diagnosed and treated. **You may be eligible if...** - You are a woman aged 18–75 - You are scheduled to have a breast duct excision (removal) surgery - You are able to give written consent and follow the study procedures **You may NOT be eligible if...** - You are pregnant or breastfeeding - You have a known allergy to the needle's materials (quantum-dot components) - You have active hepatitis B or C with detectable virus in the blood - You have unstable heart disease or severe heart failure - You have a neurological or psychiatric condition that affects your ability to comply with the study - You are already in another interventional clinical trial Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEnovel fluorescent localization marker needle

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

DEVICEconventional localization marker needle

conventional localization marker needle, without any coating


Locations(1)

The Fourth Affiliated Hospital of China Medical University

Shenyang, Liaoning, China

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NCT07339306


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