Breast CancerPhase 3ORIGONCT06597175
Evaluating Investigational Medical Device for Breast Tumor Diagnosis Using Diffusion Optical Spectroscopy
A Phase 3 study testing ORIGO in people with Breast Cancer and Breast Tumor, run by Olive Healthcare at 5 sites in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older, women only
- Conditions the study is for
- Breast Cancer, Breast Tumor, Mammary Carcinoma, Human
- What is being tested?
- ORIGO
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 5 sitesSouth Korea
- Study dates
- 16 Apr 2024to 16 Dec 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female aged 19 years or older
- ACR BI-RADS Category 3-5 (5th edition, 2023 update)
Who cannot join
- 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 locations and contacts
5 sites in 1 country.
5 sites in 1 country
South Korea5 sites
Seoul National University Bundang Hospital
Seongnam-si
Kangbuk Samsung Hospital
Seoul
Korea University Anam Hospital
Seoul
Severance Hospital
Seoul
Yongin Severance Hospital
Yongin-si
About this study
Official 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
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
- Being tested
- ORIGO
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ORIGODevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Device: ORIGO | Experimental | Not described Receives: Device: ORIGO |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concordance
Concordance between biopsy results (Gold standard) and the device test results for breast lesions in subjects
Measured: Through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start16 Apr 2024
- Primary completion29 Nov 2024
- Study completion16 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Device: ORIGO
- Masking
- None (open label)
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Olive Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06597175
- Sponsor's protocol ID
- ORIGO_E23-01
- Acronym
- ORIGO
- Status last verified
- Aug 2025
- First submitted
- 28 Aug 2024
- Last updated
- 13 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06597175
- Acronym / sponsor ID
- ORIGO / ORIGO_E23-01
- Conditions
- Breast Cancer, Breast Tumor, Mammary Carcinoma, Human
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Olive HealthcareIndustry (pharma, biotech, devices)
- Study start
- 16 Apr 2024 (actual)
- Primary completion
- 29 Nov 2024 (actual)
- Study completion
- 16 Dec 2024 (actual)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Device: ORIGO
| Arm | Type | Receives |
|---|---|---|
| Device: ORIGO | Experimental | Device: ORIGO |
Who may qualify
- Ages
- 19 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Female aged 19 years or older
- ACR BI-RADS Category 3-5 (5th edition, 2023 update)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ORIGOThe 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. | Device | Device: ORIGO |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ORIGO in people with Breast Cancer and Breast Tumor, run by Olive Healthcare at 5 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concordance (time frame: Through study completion, an average of 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2025.