Evaluation of PerioMonitor for Detection of Oral Inflammatory Load (OIL) in Human Subjects

Overview

The purpose of this multicenter, prospective, single arm Study is to evaluate the efficacy and safety of PerioMonitor as an aid to the presumptive detection of oral inflammation associated with periodontal diseases. PerioMonitor is an IVD device for the rapid, semi-quantitative detection of PMN in oral samples. This test is intended for prescription use at Point-of-Care ("POC") settings by health care professionals.

PerioMonitor is an IVD device for the rapid, semi-quantitative detection of PMN in oral samples. This test is intended for prescription use at POC settings by health care professionals. This type of In vitro diagnostic device (IVDD) is also sometimes defined as a "Near-Patient Testing" IVDD. Conducting investigational testing is a pre-requisite to obtain a Class III medical device licence in respect to in vitro diagnostic devices intended for use in POC settings (e.g., home use or outpatient dental clinic) from Health Canada. Such studies are mandatory to establish the safety and effectiveness of the device should be presented to support the performance for each claimed indication for use. They must be conducted on the device using human subjects representative of the intended users and under conditions similar to the conditions of use, to provide reasonable assurance of safety and effectiveness for the intended use. This notably includes: 1. studies to evaluate the sensitivity and the specificity of the device to provide clinically meaningful results in the target population; and 2. consumer fields evaluations, i.e., studies evaluating the performance of the device when used by the intended users without assistance, following instructions provided in the labelling. The same is also applicable in the United States of America. More specifically with respect to consumer field evaluations, FDA requires clinical data to determine whether particular tests are "simple" and have "an insignificant risk of an erroneous result" to be approved for waiver under the CLIA criteria and cleared for use in POC settings. This document is a clinical investigational plan specifically designed for the conduct of a blinded, multicenter and prospective, single arm human Study to evaluate the safety and the efficacy of PerioMonitor as an aid to the presumptive detection of oral inflammation associated with periodontal diseases. This single-arm Study is designed to be representative of the intended use of PerioMonitor as well as the intended users, intended patient population and intended environment of use. To this end, the Study will include a minimum of 117 subjects, tested by HCPs working in three different dental clinics (i.e., with the background, education, and training of those who will perform the test in its intended environment) that are not qualified laboratory technicians, with PerioMonitor.

Conditions

Eligibility

Locations (3)

Outcomes

Central Contacts