In Vivo Smart Biopsy Device Protocol In Radiology

Dune Medical Devices

Status: Unknown

Conditions: Breast Cancer; Image Guided Biopsy

Treatments: Device: Smart Biopsy Device

Study type: Interventional

Funder types: Industry

Identifiers

NCT03914911

CP-10-001

Details and patient eligibility

About

This study is designed to demonstrate the feasibility of use of the Smart Biopsy Device in real clinical settings.

Full 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.

Enrollment: 41 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

41 participants in 1 patient group

Study Arm

Experimental group

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)

Treatment:

Device: Smart Biopsy Device