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Clinical trial

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

NCT06597175 is registered in ClinicalTrials.gov with Olive Healthcare as lead sponsor.

NCT NCT06597175
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Registry record

As filed in ClinicalTrials.gov.

Title
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
Lead sponsor
Olive Healthcare
Phase
Phase 3
Overall status
Completed
Start date
April 16, 2024
Completion date
December 16, 2024
Enrollment
300 (actual)
Sites
5

Conditions

As the registry lists them; a condition with its own page is linked.

breast cancer, breast tumor, mammary carcinoma, human