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Thermalogical Analysis of a Cohort of Women and Men Undergoing Mammographic Analysis.

NCT03271853 · Status: SUSPENDED · Type: OBSERVATIONAL · Enrollment: 2000

Last updated 2018-01-10

No results posted yet for this study

Summary

This study is designed to evaluate the Sentinel BreastScan II as well as the analysis of data by Therma-Scan.

Conditions

  • Breast Neoplasm Female
  • Cancer, Breast
  • Thermography

Interventions

DEVICE

Sentinel BreastScan II

The SBS II will automate the recording of thermal data used in the Therma-Scan manual thermology protocol by utilizing a thermal camera sensitive to changes in breast temperature. The SBS II system uses a very sensitive thermography camera that detects and visually displays heat patterns that naturally emanate from the breast. SBS II captures this data digitally for subsequent analysis by Therma-Scan.

Sponsors & Collaborators

  • University of Toledo Health Science Campus

    collaborator OTHER

  • First Sense Medical, LLC

    lead OTHER

Principal Investigators

  • Haitham Elsamaloty · University of Toledo

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-11-03
Primary Completion
2021-09-01
Completion
2026-09-01
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 NCT03271853 on ClinicalTrials.gov