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Trial Title:
Evaluating Investigational Medical Device for Breast Tumor Diagnosis Using Diffusion Optical Spectroscopy
NCT ID:
NCT06597175
Condition:
Breast Cancer
Breast Tumor
Mammary Carcinoma, Human
Conditions: Official terms:
Breast Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
Device: ORIGO
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Device
Intervention name:
ORIGO
Description:
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.
Arm group label:
Device: ORIGO
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.
Criteria for 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
Gender:
Female
Minimum age:
19 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Seoul National University Bundang Hospital
Address:
City:
Seongnam-si
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
SunMi Kim, Dr.
Facility:
Name:
Kangbuk Samsung Hospital
Address:
City:
Seoul
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Inyoung Yoon, Dr.
Facility:
Name:
Korea University Anam Hospital
Address:
City:
Seoul
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Sung Eun Song, Dr.
Facility:
Name:
Severance Hospital
Address:
City:
Seoul
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Min Jung Kim, Dr.
Facility:
Name:
Yongin Severance Hospital
Address:
City:
Yongin-si
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Si Eun Lee
Contact backup:
Last name:
Si Eun Lee, Dr.
Start date:
April 16, 2024
Completion date:
October 2024
Lead sponsor:
Agency:
Olive Healthcare
Agency class:
Industry
Source:
Olive Healthcare
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06597175
