Clinical trial · Observational
Comparison of First Sense Breast Exam® to the University of Toledo Mammography and Biopsy Results
NCT02633605CI-TRIAL-00030754completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| First Sense Medical® | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- First Sense Breast Exam
- interventionNames
- Device: First Sense Medical®
Primary outcomes (1)
- measure
- Percentage of breast cancer cases detected by the new medical device (the First Sense Medical technology)
- timeFrame
- Up to 12 months
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * Subject does not meet inclusion criteria, noted above. * 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
References
Publications (0)
Data not yet available
No reference posted for this study.