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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.
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
Conditions
Interventions
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
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