N/A
Completed N=70
Carbon Monoxide Breath Sensor System Performance, Human Factors, and Usability Assessment Conducted in a Single Visit
Smoking, Tobacco
Source: ClinicalTrials.gov NCT03148613 ↗
Enrolled (actual)
70
Serious AEs
0.0%
Results posted
Oct 2022
Primary outcomePrimary: Performance Variable - Correlation of Carbon Monoxide (CO) Measurements Between COBSS and Predicate Devices — 0.9878 Correlation coefficient (R-value)
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)
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 | — |
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
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. Informational only — not medical advice.