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Clinical Evaluation of CEM-guided Biopsy

NCT05250674 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 66

Last updated 2022-02-22

No results posted yet for this study

Summary

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.

Conditions

  • Contrast Enhanced Mammography-guided Biopsy

Interventions

DEVICE

CEM-guided biopsy

The evaluation population consists of adult women, presenting with clinical indication for a breast biopsy procedure after a positive abnormal CEM or MRI examination (with no clear ultrasound or mammography correlation) and considered eligible for this procedure as per standard of care. Eligible subjects undergo the clinically indicated breast biopsy procedure using the Pristina Serena Bright ® 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.

Sponsors & Collaborators

  • General Electric

    collaborator INDUSTRY

  • Parc de Salut Mar

    lead OTHER

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-10-08
Primary Completion
2021-09-27
Completion
2021-10-06
FDA Device
Yes

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05250674 on ClinicalTrials.gov