Trials / Unknown
UnknownNCT03914911
In Vivo Smart Biopsy Device Protocol In Radiology
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 41 (actual)
- Sponsor
- Dune Medical Devices · Industry
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
This study is designed to demonstrate the feasibility of use of the Smart Biopsy Device in real clinical settings.
Detailed description
This is a single arm, multicenter study. It will be conducted in 3 medical centers, in the breast-imaging unit during ultrasonic guided core needle biopsy procedures performed in women with abnormality in the breast. The study duration is only during the biopsy procedure, and the follow up period is 2 -3 weeks.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Smart Biopsy Device | The radiologist will perform a routine ultrasonic guided biopsy procedure using the smart biopsy system, with the device readings not visible (i.e. the radiologist will be blinded to device readings) |
Timeline
- Start date
- 2019-03-14
- Primary completion
- 2020-02-28
- Completion
- 2020-03-31
- First posted
- 2019-04-16
- Last updated
- 2020-01-31
Locations
2 sites across 1 country: Israel
Source: ClinicalTrials.gov record NCT03914911. Inclusion in this directory is not an endorsement.