Evaluating Investigational Medical Device for Breast Tumo... | NCT06597175

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

NCT06597175

Sponsor

Olive Healthcare

Status

Completed

Last Update Posted

Aug 13, 2025Actual

Enrollment

300Actual

Phase

Phase 3

Conditions

Breast Cancer
Breast Tumor
Mammary Carcinoma, Human

Interventions

ORIGO

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

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

Status Module

Record Verification Date

Aug 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 16, 2024Actual

Primary Completion Date

Nov 29, 2024Actual

Completion Date

Dec 16, 2024Actual

First Submitted Date

Aug 28, 2024

First Submission Date that Met QC Criteria

Sep 11, 2024

First Posted Date

Sep 19, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 11, 2025

Last Update Posted Date

Aug 13, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

300Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Device: ORIGO	Experimental		Device: ORIGO

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ORIGO	Device	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Concordance	Concordance between biopsy results (Gold standard) and the device test results for breast lesions in subjects	Through study completion, an average of 6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul National University Bundang Hospital		Seongnam-si			South Korea
Kangbuk Samsung Hospital

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001943	Breast Neoplasms

Ancestor Terms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases

Browse Leaves

Not provided

Browse Branches

Not provided