Performance Characteristics
One study has been performed to demonstrate the clinical performance of the Pivot breath sensor. That study included 70 participants and compared the performance of the Pivot breath sensor to the Bedfont Micro+™ Smokerlyzer ®. Each participant did a breath sample on the Pivot breath sensor, and then a breath sample on the Bedfont Micro+™ Smokerlyzer ® three to five minutes later.
The overall color category agreement result of the study was 87% (61/70). That is to say, the color category of the breath sample performed on the Pivot breath sensor was the same as the color category of the breath sample performed shortly after on the Bedfont Micro+™ Smokerlyzer® 87% of the time. The agreement for each color category over the 0-100 ppm operating range of the device is shown below
Clinical Study
Overview/Study Design
- Adult smokers self-trained on and used the Pivot Breath Sensor over a 28-day period on an ambulatory basis, while living their lives as they normally would
- Assessment included attitudes towards quitting smoking, changes in smoking behavior and participant feedback on the Pivot Breath Sensor
Participants received weekly study questionnaires via email over this 28-day period. The study duration is 84 days, with primary and secondary outcomes obtained at 28 days.
The primary endpoint assessed change in motivation to quit, as measured by Stage of Change, at day 28 compared to baseline.The secondary endpoints included the proportion of participants who reported ≥ 1 quit attempt by day 28 (compared to zero) and the proportion of participants who reduced their cigarettes per day (CPD) by ≥ 50% by day 28, compared to baseline.
Outcomes
For the primary endpoint, motivation to quit smoking responses were statistically different at day 28 compared to baseline (P<.0001). Specifically, motivation improved with 38.9% (84/216) of respondents indicating they were thinking of quitting in the next 30 days compared with 14.4% (31/216) at baseline (P < .0001). At 28 days, motivation to quit smoking increased in 29.6% (64/216), was unchanged in 66.7% (144/216), and decreased in 3.7% (8/216) (P<.0001).
For the secondary endpoints, 28.2% (66/234, intention to treat or ITT) reported making ≥ 1 quit attempt by day 28, and 23.1% (54/234, ITT) reduced their CPD by ≥ 50% by day 28, compared to baseline.