N/A N=70 Other

Carbon Monoxide Breath Sensor System Performance, Human Factors, and Usability Assessment Conducted in a Single Visit

Smoking, Tobacco

Bottom Line

View on ClinicalTrials.gov: NCT03148613 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Oct 2022

Primary outcome: Primary: Performance Variable - Correlation of Carbon Monoxide (CO) Measurements Between COBSS and Predicate Devices — 0.9878 Correlation coefficient (R-value)

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Carbon Monoxide Breath Sensor System (COBSS) (Device); Bedfont - Micro+™ Smokerlyzer® (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: David Utley, MD
Primary completion: Mar 2017

Outcome Measures

Outcome	Result	p-value
PRIMARY Performance Variable - Correlation of Carbon Monoxide (CO) Measurements Between COBSS and Predicate Devices	0.9878	—
PRIMARY Human Factors - User Performance in Use Scenarios Assessment With Observer Ratings	34; 25; 59; 37; 29; 66	—
SECONDARY User Documentation Assessment With Questionnaire With Observer Ratings	23; 17; 40; 13; 10; 23	—
SECONDARY Number of Participants Answering "No" for the Subjective Feedback With Questionnaire	30; 23; 53; 33; 27; 60	—
SECONDARY Participant Assessment With Questionnaire Rating Scales	26; 8; 34; 9; 18; 27	—

Summary

Prospective, open label, single center clinical study enrolling 70 subjects to study Performance, Human Factors, and Usability for the Carbon Monoxide Breath Sensor System (COBBS)

Eligibility Criteria

Subject who self-report smoking 2 or more cigarettes each day

Inclusion Criteria

18-80 years of age
English speaking
Owns and uses a smartphone
Willing to sign the Informed Consent Form

Exclusion Criteria

Pregnancy

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03148613). 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.