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Assessing the Sensitivity of "SureTouch™" in Women Undergoing Diagnostic and Screening Mammography

NCT04397029 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 213

Last updated 2022-06-13

No results posted yet for this study

Summary

Prospective, case-control study being conducted to determine the sensitivity of the SureTouch device in detecting known masses at a pre-determined level of specificity.

Conditions

Interventions

DEVICE

SureTouch

The first group will consist of 70 women who are believed to be free of masses, recruited during a screening mammography appointment. The second group will include 125 women presenting for diagnostic mammography and/or biopsy appointment with known masses identified on mammogram, ultrasound or both. Both groups will receive breast cancer screening with mammography and SureTouch.

Sponsors & Collaborators

  • Sure, Inc.

    collaborator INDUSTRY

  • George Washington University

    lead OTHER

Principal Investigators

  • Rebecca Kaltman, MD · The George Washington University

Study Design

Allocation
NON_RANDOMIZED
Purpose
SCREENING
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
80 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-01-04
Primary Completion
2021-02-10
Completion
2021-02-10

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT04397029 on ClinicalTrials.gov