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RECRUITING
NCT07003841
NA

Evaluation of Clinical Efficacy of Augmented Reality (AR)-Based Breast Cancer Medical Imaging Solution (SKIA-Breast) Localization Method in Breast Cancer Patients

Sponsor: SKIA Inc.

View on ClinicalTrials.gov

Summary

This clinical trial aims to evaluate whether an augmented reality (AR)-based medical imaging solution (SKIA-Breast) is non-inferior to conventional ultrasound-guided skin marking in guiding breast-conserving surgery in female patients with breast cancer. Participants will be randomly assigned in a 1:1 ratio to either the AR-based group or the conventional group. All participants will undergo breast-conserving surgery according to their assigned method. The primary outcome is the negative margin resection rate evaluated by histopathological examination. The secondary outcome is the re-excision rate due to positive margins assessed by histopathological examination.

Official title: Multicenter, Randomized, Controlled, Prospective, Confirmatory Study to Evaluate the Clinical Efficacy of Augmented Reality (AR)-Based Breast Cancer Medical Imaging Solution (SKIA-Breast) Localization Method in Breast Cancer Patients Confidential Statement

Key Details

Gender

FEMALE

Age Range

19 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

94

Start Date

2025-11-19

Completion Date

2027-03-31

Last Updated

2026-03-12

Healthy Volunteers

No

Interventions

DEVICE

Surgical navigation system with stereotactic guidance

This investigational medical software device utilizes CT imaging data to project the scanned anatomy onto the patient's body, enabling augmented reality-based visualization of the lesion site before surgery

DEVICE

General ultrasound imaging system

A general diagnostic ultrasound imaging device that transmits ultrasound energy to the lesion for diagnostic purposes and visualizes the reflected signals. It supports various types of transducers and associated application software packages used for acquiring, displaying, and analyzing ultrasound data.

Locations (3)

Ewha Womans University Medical Center

Seoul, Gangseo-gu, South Korea

Seoul National University Hospital

Seoul, Jongno-gu, South Korea

Yonsei University Health System, Severance Hospital

Seoul, Seodaemun-gu, South Korea