Comparison of First Sense Breast Exam® to the University of Toledo Mammography and Biopsy Results

NCT02633605 | Completed FDA Device

• 1 other identifier: FSM-002
• Study Type: observational
• Target: 358
• Locations: 1 country
• Sites: 1

Brief Summary

First Sense Medical®, LLC is a medical device company developing a novel breast cancer screening tester called the First Sense Breast Exam® Tester. This radiation free tester is being developed to produce data which will be analyzed by Therma-Scan Reference Laboratory. When the tester is in production, a test will take approximately 7 minutes and will be performed in a doctor's office.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Percentage of breast cancer cases detected by the new medical device (the First Sense Medical technology)

  Up to 12 months

Study Arms (1)

First Sense Breast Exam

Device: First Sense Medical®

Interventions

First Sense Medical® DEVICE

First Sense Breast Exam

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population is comprised of adult women who are having a diagnostic or screening mammogram.

You may qualify if:

• Female, over the age of 18 years of age.
• Asymptomatic women and women who are being screened for breast abnormality.
• Women scheduled for a mammogram or women who have had a mammogram and are given 3 days to wait in between their mammogram and scheduled biopsy and FS/TS system.
• Not pregnant or breast feeding.
• Signed Informed consent.

You may not qualify if:

• Use of niacin or niacin patch.
• Use of nitroglycerin.
• Subject experienced a fever of 102°F or higher within thirty-six (36) hours of the study.
• Patients with any prior breast surgery (implants, reduction, lumpectomy, mastectomy, mastopexy, reconstruction and incisional biopsies.).
• History of breast cancer

Sponsors & Collaborators

• First Sense Medical, LLC: lead

Study Sites (1)

Eleanor N. Dana Cancer Center

Toledo, Ohio, 43614, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2015
• First Posted: December 17, 2015
• Study Start: January 1, 2016
• Primary Completion: October 21, 2016
• Study Completion: October 21, 2016
• Last Updated: December 11, 2017

Record last verified: 2017-12

Locations

US (1)