Clinical trial · Observational
Development of Assist Tool for Breast Examination Using the Principle of Ultrasonic Sensor
Development of Assist Tool for Breast Examination Using the Principle of Ultrasonic Sensor : A Development and Validation Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Artificial Intelligence | — | UNRESOLVED | — |
| Benign Breast Disease | — | UNRESOLVED | — |
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Breast Neoplasm | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Ultrasonography | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- Ultrasonic group
Primary outcomes (1)
- measure
- Device performance
- timeFrame
- Within 1 year after the study participant registration deadline
- description
- Sensitivity/specificity/predictive value/accuracy/positive predictive value/ negative predictive value of diagnostic performance
Secondary outcomes (1)
- measure
- Artificial intelligence algorithm efficacy
- timeFrame
- Within 2 year after the study participant registration deadline
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * female patients between 18 and 80 years of age who are scheduled for surgery after a tumor has been confirmed on breast ultrasound examination Exclusion Criteria: * 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
References
Publications (0)
Data not yet available