N/A N=70 Other

Pivot Breath Sensor Performance Study

Smoking Cessation · Smoking, Tobacco

Bottom Line

View on ClinicalTrials.gov: NCT03870022 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Nov 2022

Primary outcome: Primary: User Performance of Pivot Breath Sensor — 68; 2; 70; 0 Participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Pivot Breath Sensor System (Device); Similar Carbon Monoxide breath sensor system (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Jennifer Marler, MD
Primary completion: Apr 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY User Performance of Pivot Breath Sensor	68; 2; 70; 0	—
PRIMARY Compare Performance of Pivot Breath Sensor With a Similar Device.	0.9710	—
SECONDARY User Documentation Assessment With Observer Ratings	69; 1; 57; 13; 70; 0	—
SECONDARY Participant Feedback Using Rating Scale	27; 32; 9; 2; 0; 0	—

Summary

A clinical study enrolling 70 subjects to: * evaluate the user performance of the Pivot Breath Sensor * compare measurements from the Pivot Breath Sensor to a similar device * assess user documentation comprehension * obtain feedback on the Pivot Breath Sensor via rating scales. No medical decisions will be made related to test results.

Eligibility Criteria

Inclusion Criteria

18-80 years of age
Owns and uses a smartphone
Willing to sign the Informed Consent Form
Resident of the United States
Able to read and comprehend English

Exclusion Criteria

Prior experience with a study sponsored by Carrot Inc.
Pregnancy

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03870022). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.