NCT06597175
Completed
Phase 3
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
Olive Healthcare5 sites in 1 country300 target enrollmentApril 16, 2024
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Breast Cancer
- Sponsor
- Olive Healthcare
- Enrollment
- 300
- Locations
- 5
- Primary Endpoint
- Concordance
- Status
- Completed
- Last Updated
- 8 months ago
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Concordance
Time Frame: Through study completion, an average of 6 months
Concordance between biopsy results (Gold standard) and the device test results for breast lesions in subjects
Study Sites (5)
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