Recruiting
Phase 1
Phase 2

Observational Study

Sponsor:

Cyrcadia Health

Code:

NCT02511301

Conditions

Early-Stage Breast Carcinoma

Eligibility Criteria

Sex: Female

Age: 21+

Healthy Volunteers: Not accepted

Interventions

Cyrcadia CBR™ device placement for abnormality screening

Study Details

Brief summary:

The purpose of this study is to determine if Cyrcadia's Circadian Biometric Recorder (CBR™), which is attached to soft biometric patches worn on the body, can improve early breast cancer detection along with mammography or as a stand alone device.

Conditions

Early-Stage Breast Carcinoma

Study ID

NCT02511301

Start date

Jun, 2015

Status verified date

Dec, 2018

Completion date

Feb, 2020

Anticipated

Primary completion date

Feb, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 21+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Women with a BI-RADS category 4 or 5 designation on mammogram
  • Women with a BI-RADS category 4 or 5 designation on breast ultrasound
  • Women with a BI-RADS category 4 or 5 designation on breast MRI
  • Women who are willing to undergo a complete evaluation and/or biopsy procedure if recommended by the treating physician

Exclusion Criteria:

  • Less than 21 years of age
  • Unable to sign the consent form
  • Pregnant or lactating
  • Physically unable to wear the Cyrcadia CBR™ for 6 hours
  • Previous mastectomy
  • Any breast surgery or biopsy within the last 90 days
  • Any trauma to the breast within the last 90 days
  • Any biopsy or treatment for the BI-RADS category 4 or 5 abnormality
  • Refusal to undergo recommended diagnostic evaluation of the BI-RADS category 4 or 5 abnormality

Study Design

Enrollment

173 participants

Anticipated

Intervention Model

Single group

Primary purpose

Screening

Interventions and Outcome Measures

Arms

experimental: Cyrcadia CBR™ Device

Cyrcadia CBR™ device, including adhesive patches on both breasts connected to a small recorder, is placed on the study subject for 2 to 24 hours. After the test period, the CBR™ will be removed and the data will be downloaded to a central site for analysis.There are no interventions after the CBR™ is removed from the Study Subject

Interventions

Cyrcadia CBR™ device placement for abnormality screening

Cyrcadia CBR™ device, including adhesive patches on both breasts connected to a small recorder, is placed on the study subject for 2 to 24 hours. After the test period, the CBR™ will be removed and the data will be downloaded to a central site for analysis. There are no interventions after the CBR™ is removed from the Study Subject.

Primary outcome measure

  • Predictive Analytic Analysis (PAA) Sensitivity and Specificity [ Time Frame: 7 to 30 days after CBR placement ]

Central Contacts and Locations

Central contacts

Marie Norell, B.A., CCRA

775-233-1211manorell@cyrcadiahealth.com

Locations

El Camino Hospital

Recruiting

Mountain View, California, United States, 94040-4378

Contacts

Kara Amber, B.S., CCRP

650-962-4562kara_amber@elcaminohospital.com

More Information

Sponsor

Cyrcadia Health

Last update posted

Jan 3, 2019

Last verified

Dec, 2018

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Cyrcadia Health on 2019-01-03.