Evaluating Investigational Medical Device for Breast Tumor Diagnosis Using Diffusion Optical Spectroscopy (ORIGO)

A Multi-center, Open-label, Single Arm, Prospective Pivotal Medical Device Clinical Trial to Evaluate Efficacy and Safety of Study Device (ORIGO) That Provides Numerical Data by Measuring the Composition Within Breast Tissue Using Diffusion Optical Spectroscopy Imaging Technology to Assist in the Differential Diagnosis of Breast Tumors in Patients With Breast Lesions

This is a multicenter, pivotal clinical trial to evaluate the safety and efficacy of a diagnostic device used to assist in the differentiation of breast tumors in patients with breast lesions detected by ultrasound alone or by both ultrasound and mammography.

Study Overview

• Status: Completed
• Conditions: Breast Cancer; Breast Tumor; Mammary Carcinoma, Human
• Intervention / Treatment: Device: ORIGO

• Study Type: Interventional
• Enrollment (Actual): 300
• Phase: Phase 3

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seongnam-si, Korea, Republic of
    • Seoul National University Bundang Hospital
  • Seoul, Korea, Republic of
    • Severance Hospital
  • Seoul, Korea, Republic of
    • Korea University Anam Hospital
  • Seoul, Korea, Republic of
    • Kangbuk Samsung Hospital
  • Yongin-si, Korea, Republic of
    • Yongin Severance Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Female aged 19 years or older
• ACR BI-RADS Category 3-5 (5th edition, 2023 update)

Exclusion Criteria:

• Pregnant, potentially pregnant, or currently breastfeeding
• Calcifications detected on mammography but do not have corresponding lesions identified on ultrasound
• Biopsy performed on the same breast within 7 days prior to the date of informed consent
• Significant trauma or scarring at the measurement site, or those suffering from mastitis.
• Breast implants, electronic medical devices such as pacemakers, or with a space left in the breast cavity due to implant removal
• History of phototoxic reactions or light sensitivity

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Device: ORIGO	Device: ORIGO; The device measurement is first performed on the breast area with the lesion, followed by the measurement of the corresponding area in the contralateral breast for comparison.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Concordance	Concordance between biopsy results (Gold standard) and the device test results for breast lesions in subjects	Through study completion, an average of 6 months

Collaborators and Investigators

• Sponsor: Olive Healthcare

Study record dates

Study Major Dates

• Study Start (Actual): April 16, 2024
• Primary Completion (Actual): November 29, 2024
• Study Completion (Actual): December 16, 2024

Study Registration Dates

• First Submitted: August 28, 2024
• First Submitted That Met QC Criteria: September 11, 2024
• First Posted (Actual): September 19, 2024

Study Record Updates

• Last Update Posted (Actual): August 13, 2025
• Last Update Submitted That Met QC Criteria: August 11, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: ORIGO_E23-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No