‍Aim

The aim oft he study was to validate the reliability of relative compartment compressibility measurements using the CPMX1 device by Compremium in healthy volunteers. Additionally, the study was meant to validate the number of measurement repetitions for optimal repeatability and to evaluate the safety of the device.

Intervention

Three independent investigators from the University Emergency Department at the University Hospital, Inselspital Bern conducted 504 compressibility ratio measurements on 42 different compartments in healthy volunteers.

Discussion

The primary objective was exceeded, with results showing precise and consistent measurements for all three investigators and an excellent Interclass Correlation Coefficient ICC of 0.911 with a 95% CI and a p-value of p<0.01. The secondary objective was to validate the number of measurement repetitions for optimal outcomes. It showed that one repetition provides very satisfactory results (see figure 3 below). No adverse events were reported.

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Figure 1: Visual of achieved Interclass Correlation Coefficient (ICC) in the clearance study.

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Figure 2: Inter-operator reproducibility (overview).

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Figure 3: ICC (2,3) and 95% CI by number of measurements.

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The study is part of the 510(k) filing for FDA approval for the CPMX1 device by Compremium.

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Formalities

The study was approved by the Ethics Committee of Bern (EC) and Swissmedic, the competent authority (CA), prior to its initiation. The study was carried out in accordance with the protocol and with principles enunciated in the current version of the Declaration of Helsinki, the ISO 14155 and ISO 14971 norms, ICH-GCP as far as applicable, the Swiss Law and the Swiss regulatory authority’s requirements.

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‍ Disclaimer

The CPMX1 has received FDA clearance for the following indication for use: “The Compartmental Compressibility Monitoring System (CPM#1) is intended for real-time and intermittent monitoring of relative compartment compressibility. The relative compartment compressibility (CP Value) is not meant for trend analysis.”

Healthcare professionals can apply to become an investigator and obtain the device for investigational use by sending a request to info@compremium.ch