Analysis, Event History Clinical Trial
Official title:
An Open, Non-randomised, Study to Provide a Comparison of Data From a Conventional Blood Gas Analyser With Those Obtained From the CE Marked Proxima System
This clinical investigation is being undertaken to examine the performance of the CE marked
Proxima System - a patient attached blood gas analyser.
The study forms an element of the Post Market surveillance plan for the Proxima system and
will also generate method comparison data to allow Sphere Medical to submit the Proxima for
FDA regulatory clearance.
The PROX006 study is an open and non-randomised study that will be conducted to assess the
performance of the Proxima (a CE marked Medical Device)on a wide range of patients with a
variety of conditions. This study will allow the performance of the Proxima and the
institution's conventional blood gas analyser to be compared when used in the Intensive Care
Unit and Operating Theatre.
The PROX006 investigation is an observational method comparison study - the results obtained
from the Proxima will be compared with those obtained on the institution's conventional
blood gas analyser (BGA). The potential for bias by the user will be negated in this study
by directly comparing the results from the BGA and Proxima.
The data/results documented in the Case Report Form (CRF) will be verified during monitoring
visits.
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Observational Model: Case-Only, Time Perspective: Prospective
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