Clinical Evaluation of CEM-guided Biopsy

Parc de Salut Mar

Status: Completed

Conditions: Contrast Enhanced Mammography-guided Biopsy

Treatments: Device: CEM-guided biopsy

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT05250674

2019-8890

Details and patient eligibility

About

CEM-guided biopsy is an optional accessory of Senographe Pristina intended to provide accurate location of lesions in the breast in three dimensions, using information obtained from Contrast Enhanced Mammography (CEM) images. This information provides guidance for a variety of minimally invasive or interventional procedures in the breast such as vacuum assisted biopsy, core biopsy, presurgical localization (e.g. hook wire), and fine needle aspirations (FNA). This device cannot be used for reasons other than its intended use.

This evaluation is being done to learn more about the CEM-guided biopsy. Clinical user and operational feedback is a central part of the development process for medical devices in which information from real clinical use is required to optimize the device prior to commercial release.

Full description

Pristina Serena CEM is an option to the standard Pristina Serena breast biopsy unit. It is designed to allow the accurate localization of lesions in the breast in three dimensions, using information obtained from Contrast Enhanced Mammography (CEM) images. It is intended to provide guidance for histological purposes such as core or vacuum-assisted biopsies, for pre-surgical localization procedures, or Fine Needle Aspiration (FNA) for cytopathology analysis.

The main purpose of this evaluation is to collect feedback to assess image readability and look-and feel, usability, workflow and user preference information from physicians and technologists who use CEM-guided biopsy to perform minimally invasive interventional breast procedures under clinical conditions. All feedbacks are collected by observations, interviews and surveys.

The evaluation population consists of adult women, presenting with clinical indication for a breast biopsy procedure after a positive abnormal CEM or MRI examination, and considered eligible for this procedure as per standard of care.

Eligible subjects undergo the clinically indicated breast biopsy procedure using the Pristina Serena CEM-guided biopsy. Region of interest location is determined by using stereotactic pairs of CEM images after injection of iodinated contrast media. All necessary equipment and instrumentation, medications, or other devices required to complete the subject's clinically indicated procedure shall be used and are not expected to be influenced by evaluation participation.

Enrollment: 66 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Adult women presenting with clinical indication for a breast biopsy procedure after a positive abnormal CEM or MRI examination, and considered eligible for this procedure as per standard of care.
• Are able and willing to comply with study procedures
• Are able and willing to provide written informed consent to participate

Exclusion criteria

• Findings not accessible for stereotactic guidance biopsy
• Are currently lactating
• Have breast implants

Trial design

66 participants in 1 patient group

Adult women with indication for a breast biopsy procedure after an abnormal CEM or MRI examination.

Description:

Adult women presenting with clinical indication for a breast biopsy procedure after a positive abnormal CEM or MRI examination and no clear ultrasound or mammography correlation.

Treatment:

Device: CEM-guided biopsy