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
1 other identifier
interventional
300
1 country
5
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 breast-cancer
Started Apr 2024
Shorter than P25 for phase_3 breast-cancer
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 16, 2024
CompletedFirst Submitted
Initial submission to the registry
August 28, 2024
CompletedFirst Posted
Study publicly available on registry
September 19, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 29, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 16, 2024
CompletedAugust 13, 2025
August 1, 2025
8 months
August 28, 2024
August 11, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
Device: ORIGO
EXPERIMENTALInterventions
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.
Eligibility Criteria
You may qualify if:
- Female aged 19 years or older
- ACR BI-RADS Category 3-5 (5th edition, 2023 update)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Olive Healthcarelead
Study Sites (5)
Seoul National University Bundang Hospital
Seongnam-si, South Korea
Kangbuk Samsung Hospital
Seoul, South Korea
Korea University Anam Hospital
Seoul, South Korea
Severance Hospital
Seoul, South Korea
Yongin Severance Hospital
Yongin-si, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 28, 2024
First Posted
September 19, 2024
Study Start
April 16, 2024
Primary Completion
November 29, 2024
Study Completion
December 16, 2024
Last Updated
August 13, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will not share