Breast Cancer, Breast Tumor, Mammary Carcinoma, Human
Conditions
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.
Interventions
DEVICEORIGO
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.
Sponsors
Olive Healthcare
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
Device: ORIGO
Eligibility
Sex/Gender
FEMALE
Age
19 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Concordance | Through study completion, an average of 6 months | Concordance between biopsy results (Gold standard) and the device test results for breast lesions in subjects |
Countries
South Korea
Outcome results
None listed