Last reviewed · How we verify
NCT06597175: ORIGO
Evaluating Investigational Medical Device for Breast Tumor Diagnosis Using Diffusion Optical Spectroscopy
Phase 3 trial testing ORIGO in Breast Cancer in 300 participants. Completed in 16 December 2024.
29 November 2024
Quick facts
| Lead sponsor | Olive Healthcare |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | diagnostic |
| Enrollment | 300 |
| Start date | 16 April 2024 |
| Primary completion | 29 November 2024 |
| Estimated completion | 16 December 2024 |
| Sites | 5 locations across South Korea |
Drugs / interventions tested
- ORIGO
Conditions studied
- Breast Cancer — all drugs for Breast Cancer →
- Breast Tumor — all drugs for Breast Tumor →
- Mammary Carcinoma, Human — all drugs for Mammary Carcinoma, Human →
Sponsor
Olive Healthcare
Who can join
19 and older, female only, with Breast Cancer or Breast Tumor. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT06597175
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06597175 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Olive Healthcare
- Last refreshed: 13 August 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06597175.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing