Evaluating Investigational Medical Device for Breast Tumor Diagnosis Using Diffusion Optical Spectroscopy
NCT ID: NCT06597175
Last Updated: 2025-08-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
300 participants
INTERVENTIONAL
2024-04-16
2024-12-16
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Device: ORIGO
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* ACR BI-RADS Category 3-5 (5th edition, 2023 update)
Exclusion Criteria
* 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
19 Years
FEMALE
No
Sponsors
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Olive Healthcare
INDUSTRY
Responsible Party
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Locations
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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
Countries
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Other Identifiers
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ORIGO_E23-01
Identifier Type: -
Identifier Source: org_study_id
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