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

August 11, 2025 updated by: Olive Healthcare

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

300

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seongnam-si, Korea, Republic of
        • Seoul National University Bundang Hospital
      • Seoul, Korea, Republic of
        • Severance Hospital
      • Seoul, Korea, Republic of
        • Korea University Anam Hospital
      • Seoul, Korea, Republic of
        • Kangbuk Samsung Hospital
      • Yongin-si, Korea, Republic of
        • Yongin Severance Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Device: ORIGO
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Through study completion, an average of 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Olive Healthcare

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 16, 2024

Primary Completion (Actual)

November 29, 2024

Study Completion (Actual)

December 16, 2024

Study Registration Dates

First Submitted

August 28, 2024

First Submitted That Met QC Criteria

September 11, 2024

First Posted (Actual)

September 19, 2024

Study Record Updates

Last Update Posted (Actual)

August 13, 2025

Last Update Submitted That Met QC Criteria

August 11, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ORIGO_E23-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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