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

Olive Healthcare

Status and phase: Completed; Phase 3

Conditions: Breast Cancer; Mammary Carcinoma, Human; Breast Tumor

Treatments: Device: ORIGO

Study type: Interventional

Funder types: Industry

Identifiers

NCT06597175

ORIGO_E23-01

Details and patient eligibility

About

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.

Enrollment: 300 patients

Sex: Female

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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300 participants in 1 patient group

Device: ORIGO

Experimental group

Treatment:

Device: ORIGO