Pivot Breath Sensor Human Factors and Usability Study



Status:Recruiting
Conditions:Smoking Cessation
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:18 - 80
Updated:2/10/2019
Start Date:February 4, 2019
End Date:May 2019
Contact:Kristine Wong
Email:kristine@carrot.co
Phone:4155770592

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Prospective, observational open label, single center study enrolling up to 15 subjects to
evaluate human factors and usability of the Pivot Breath Sensor.

The objectives of this Human Factors/Usability study are to:

- Ensure that representative intended users are able to operate the Pivot Breath Sensor
independently

- Validate appropriate mitigations of use related hazards identified in risk management
documentation

- Uncover previously unforeseen use errors

This human factors and usability testing is conducted to demonstrate that the Pivot Breath
Sensor can be used by the intended users without serious use errors or problems, for the
intended uses and under the expected use conditions.

Inclusion Criteria:

- 18-80 years of age

- English speaking

- Owns and uses a smartphone

- Willing to sign the Informed Consent Form

Exclusion Criteria:

- Prior experience with a study sponsored by Carrot Inc

- Pregnancy
We found this trial at
1
site
Redwood City, California 94063
Principal Investigator: Jennifer Marler, MD
Phone: 415-577-0592
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mi
from
Redwood City, CA
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