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Safety and Performance of the Multi-Modal UltraSound Tomography (MUST) Device in Breast Cancer Screening

NCT04102722 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1333

Last updated 2020-01-18

No results posted yet for this study

Summary

This is a single-center, pilot study being conducted to evaluate the safety and performance of the investigational device (MUST) in detecting malignant lesions in breast tissue.

Conditions

  • Breast Cancer Screening

Interventions

DEVICE

MUST device

Imaging with MUST device

Sponsors & Collaborators

  • Transonic Imaging, Inc.

    lead INDUSTRY

Principal Investigators

  • Tejas Mehta, MD · Beth Israel Deaconess Hospital

Study Design

Allocation
NA
Purpose
SCREENING
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
40 Years
Max Age
74 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-01-14
Primary Completion
2020-11-30
Completion
2021-11-30
FDA Device
Yes

Countries

  • United States

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 NCT04102722 on ClinicalTrials.gov