A Study to Evaluate the Safety and Diagnostic Performance of the BIRADx System for Breast Tumor Assessment Before Biopsy or During Breast Cancer Surgery

A Prospective, Single-Arm, Open-Label, Observational Post-Market Surveillance and Performance Evaluation Study to Assess the Safety and Real-World Diagnostic Performance of the Electronic Clinical Breast Examination BIRADx System (BDS) in Breast tumors Evaluation before Biopsy or During Breast Cancer Surgery. - PMS-BDS

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2026/06/113143

Enrollment

100

Registered

2026-06-29

Start date

Unknown

Completion date

Unknown

Last updated

2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: N630- Unspecified lump in unspecified breast Health Condition 2: D249- Benign neoplasm of unspecified breast Health Condition 3: C509- Malignant neoplasm of breast of unspecified site

Interventions

Intervention1: NA: NA Control Intervention1: Not Applicable: Not Applicable

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients with BI-RADS3, BI-RADS4, and BI-RADS5 breast masses larger than 8 mm size. 2. Patients aged 18 to 75 years 3. BI-RADS 3, 4, or 5 lesions greater than or equal to 8 mm. 4. Patient undergoing standard or ultrasound-guided diagnostic evaluation 5. Patients who provide signed informed consent

Exclusion criteria

Exclusion criteria: 1. Patients with non-palpable lesions. 2. Patient with Contraindication for impedance-based assessment. 3. Patients with prior biopsy or excision in the same region.

Design outcomes

Primary

Measure	Time frame
1.Sensitivity, specificity, and overall diagnostic accuracy of the BIRADx System (BDS) in detecting malignant breast lesions. 2.Concordance analysis between BDS findings, BI-RADS classification, and histopathological results.Timepoint: At the time of examination (baseline) before biopsy or during breast cancer surgery With BDS findings and results as per BI-RADS classification, and histopathological results after biopsy/surgery (within ~7 14 days).	—

Measure

Time frame

1.Sensitivity, specificity, and overall diagnostic accuracy of the BIRADx System (BDS) in detecting malignant breast lesions. 2.Concordance analysis between BDS findings, BI-RADS classification, and histopathological results.Timepoint: At the time of examination (baseline) before biopsy or during breast cancer surgery With BDS findings and results as per BI-RADS classification, and histopathological results after biopsy/surgery (within ~7 14 days).

—

Secondary

Measure	Time frame
1. Reduction rate of unnecessary biopsies in BI-RADS 3 lesions. 2. Proportion of early-stage malignancies detected among BI-RADS 3 patients. 3. Impact of BDS findings on clinical & radiological decision-making. 4. Verification performance of BDS in confirming BI-RADS 5 positive diagnoses prior to surgical procedure. Timepoint: 15 days after enrollment.	—

Countries

India

Contacts

Public ContactRavinder Sahoo

All India Institute of Medical Sciences, New Delhi, India

Jyoutishman@gmail.com9612892050

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Sep 19, 2026