“ARTSENS® Pen – portable easy-to-use device
for carotid stiffness measurement: technology validation and clinical utility assessment”,Biomedical Physics and Engineering Express, vol. 6, pp. 1–12, 2020.
Clinical Study at VHS Hospital
Technology Validation of ARTSENS® Pen
ARTSENS Pen was clinically validated by performing an in-vivo study on a cohort of 523 subjects. Its performance and accuracy were compared against a clinical grade ultrasound imaging system ALOKA eTracking (ProSound Alpha 10, Aloka Co., Ltd., Mitaka-shi, Japan).
Collaborators
The study was performed in collaboration with Voluntary Health Services (VHS) multispeciality hospital & research institute, Chennai.
Subjects who came to the VHS hospital for routine examination and other healthy volunteers were recruited opportunistically. All the measurements from ARTSENS Pen (sitting posture) were compared against those given by ALOKA eTracking (supine posture).
Results and Observations
1. The measurements of β, EP, and PWVβ performed by the ARTSENS Pen strongly correlated (r > 0.80, p < 0.0001) with the measurements obtained by the ALOKA system, with the highest correlation co-efficient observed for PWVβ measurements.
2. The Bland-Altman analysis demonstrated a significant agreement between ARTSENS Pen measurements and ALOKA measurements with a statistically non-significant mean bias.
3. Inter-trial variability of measurements done by ARTSENS Pen was comparable to the measurements done by the imaging system, demonstrating the ability of the ARTSENS Pen to perform repeatable measurements.
4. The ARTSENS Pen indeed yielded highly repeatable measurements (with CoV < 10%) on a relatively larger percentage of the population when compared to the ALOKA system.
5. The ability of ARTSENS Pen to capture subtle age-related stiffness changes was also demonstrated in the study. Comparing the usability of ARTSENS Pen against a traditional ultrasound imaging system, it performed fully automated measurements featuring one-touch operation that demands minimal operator intervention and expertise.
Linear correlation between ARTSENS Pen & ALOKA estimates of β, EP, and PWVβ
Bland-Altman plots comparing β, EP, & PWVβ given by the ARTSENS Pen & ALOKA
The clinical validation study has demonstrated
The usability, amenability for the clinical setting, measurement accuracy, and repeatability of the ARTSENS Pen, proving its potential utility in primary or secondary care facilities & the field scenarios.
