NCT03271853

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

• Status: Suspended
• Phase: —
• Study type: Observational
• Enrollment: 2,000 (estimated)
• Sponsor: First Sense Medical, LLC · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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

Detailed description

FirstSense Medical, LLC is a medical device company which has developed a breast cancer screening device, the Sentinel BreastScan II \[SBS II\]. This radiation free device is being developed to produce data which will be analyzed by Therma-Scan Reference Laboratory. Dr. Hoekstra, CEO of Therma-Scan, is the author of a published paper based on breast thermal data with a reported 95% sensitivity and 91% specificity. The SBS II examination will take approximately 7 minutes. This study is designed to evaluate the Sentinel BreastScan II as well as the analysis of data by Therma-Scan. SBS II thermal breast data is an adjunctive aid to standard breast imaging. Currently, mammography is one of the standards of care in screening for visible signs of breast cancer. Breast thermology is the analysis of the heat signature data from an examined breast. All study costs will be incurred by the sponsor. Study subjects will incur no cost to participate. All scientific data revealed in this protocol will be used for the specific objectives of the study. The SBS II is a non-significant risk device. There is no contact with the subject during the entire procedure.

Conditions

• Breast Neoplasm Female
• Cancer, Breast
• Thermography

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2017-11-03
• Primary completion: 2021-09-01
• Completion: 2026-09-01
• First posted: 2017-09-05
• Last updated: 2018-01-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study