NCT06597175

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 300 (actual)
• Sponsor: Olive Healthcare · Industry
• Sex: Female
• Age: 19 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Cancer
• Breast Tumor
• Mammary Carcinoma, Human

Interventions

Type	Name	Description
DEVICE	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.

Timeline

• Start date: 2024-04-16
• Primary completion: 2024-11-29
• Completion: 2024-12-16
• First posted: 2024-09-19
• Last updated: 2025-08-13

Locations

5 sites across 1 country: South Korea