NCT06255808

Completed

Development of Assist Tool for Breast Examination Using the ...

Seoul National University Hospital Source

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Other study identifiers

Sponsor study identifier

2209-039-1357

Study Type

observational

Actual enrollment (reported)

200

Locations

1 country

Sites

1

Timeline

Study Start

October 5, 2022

Actual (reported)

Primary Completion

January 5, 2024

Actual (reported)

Study Completion

January 5, 2025

Actual (reported)

Brief Summary

The accuracy of breast examinations and ultrasonography performed clinically to detect breast mass varies greatly depending on the physician\'s skill level, and the accuracy of breast examinations by non-experts is particularly low. In this study, we aimed to validate whether the concurrent use of ultrasound sensor technology is an efficient strategy for the purpose of improving the sensitivity of detecting breast masses through breast examination.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 200 participants
Study completion date: January 5, 2025
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
October 5, 2022
Actual (reported)
Primary Completion
January 5, 2024
Actual (reported)
First Submitted
February 4, 2024
Actual (reported)
First Posted
February 13, 2024
Actual (reported)
Study Completion
January 5, 2025
Actual (reported)

Last Updated: October 6, 2026
Status Verified: October 2026
Last Update Submitted: October 3, 2026

Conditions

Artificial Intelligence Benign Breast Disease Breast Cancer Breast Neoplasm Ultrasonography

Outcome Measures

Primary Outcomes (1)

Device performance
Sensitivity/specificity/predictive value/accuracy/positive predictive value/ negative predictive value of diagnostic performance
Within 1 year after the study participant registration deadline

Secondary Outcomes (1)

Artificial intelligence algorithm efficacy
Within 2 year after the study participant registration deadline

Study Arms (1)

Ultrasonic group

Eligibility Criteria

Age18 Years - 80 Years

Sexfemale

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

scheduled for surgery after a tumor has been confirmed on breast ultrasound examination

You may qualify if:

female patients between 18 and 80 years of age who are scheduled for surgery after a tumor has been confirmed on breast ultrasound examination

Sponsors & Collaborators

Seoul National University Hospital
Otherlead

Study Sites (1)

Seoul National University Hospital

Seoul, Seoul, 03080, South Korea

MeSH Terms

Conditions

Breast NeoplasmsCystic Fibrosis

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesPancreatic DiseasesDigestive System DiseasesLung DiseasesRespiratory Tract DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInfant, Newborn, Diseases

Enrollment

200 participants (actual enrollment reported by the registry).

Study Design

Study Type: observational
Observational Model: COHORT
Time Perspective: PROSPECTIVE
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Professior

Study Record Dates

First Submitted

February 4, 2024

First Posted

February 13, 2024

Study Start

October 5, 2022

Actual (reported)

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Phase 3Recruiting

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Recruiting

NCT04619186

Diffusion-Weighted MRI for Breast Cancer Screening in Women With a Personal History of Breast Cancer

Suspended

NCT04098640

Molecular Profiling in Young (<50 Years of Age) Patients With Metastatic Breast Cancer

Not ApplicableEnrolling By Invitation

You may not qualify if:

Patients diagnosed with breast cancer after biopsy with non-mass enhancement or calcification
Inflammatory breast cancer
Patients whose cancer has invaded the skin and broken through
Patients with skin diseases
Women who refused to participate in the study

Contact the study team to confirm eligibility.

Primary Completion

January 5, 2024

Actual (reported)

Study Completion

January 5, 2025

Actual (reported)

Last Updated

October 6, 2026

Record last verified: 2026-10

Data Sharing

IPD Sharing: Will not share

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT06255808
Data provider: ClinicalTrials.gov
Source updated: 2026-10-06
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:31:00 UTC

Locations

KR(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

First Submitted

First Posted

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (1)

Ultrasonic group

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations