Clinical trial · Interventional
In Vivo Smart Biopsy Device Protocol In Radiology
NCT03914911CI-TRIAL-00043118unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- 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)
This study is designed to demonstrate the feasibility of use of the Smart Biopsy Device in real clinical settings.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Image Guided Biopsy | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Smart Biopsy Device | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Study Arm
- description
- The radiologist will perform a routine ultrasonic guided biopsy procedure using the Smart Biopsy Device, with the device readings not visible (i.e. the radiologist will be blinded to device readings)
- interventionNames
- Device: Smart Biopsy Device
Primary outcomes (3)
- measure
- Incidence of adverse events (AEs) and serious adverse events (SAEs) Adverse events (AEs)
- timeFrame
- The subjects will be followed for a period of 2 -3 weeks following the biopsy procedure
- description
- AEs will be documented during the biopsy procedure and SAEs will be followed up to 3 weeks after the biopsy procedure. Rates of adverse events such as bleeding, hematoma, infection and pain will be compared to adverse events for similar procedures published in the literature and anticipated in the product risk analysis.
- measure
- Correlation between pathology results and device readings
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Women over 18 years of age * Undergoing ultrasonic guided core needle biopsy procedure due to abnormality in the breast * Signed Informed Consent Form Exclusion Criteria: * Concurrent infectious disease * Pregnancy or breastfeeding * Participating in any other investigational study for either drug or device which can influence collection of valid data under this study * Implanted devices / Implants in the operated breast
References
Publications (0)
Data not yet available
No reference posted for this study.