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| General |
| Study Status |
Study Pending |
Application Number /
Requirement Number |
P230032 / PAS001 |
| Date Original Protocol Accepted |
02/16/2024
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| Date Current Protocol Accepted |
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| Study Name |
AvertD Post-Approval Study
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| Device Name |
AvertD and AvertD Buccal Sample Collection Kit
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| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
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| Data Source |
New Data Collection
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| Comparison Group |
Device Subjects Serve as Own Control
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| Analysis Type |
Descriptive
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| Detailed Study Protocol Parameters |
| Study Objectives |
The PAS for AvertD is a prospective open-label study intended to assess AvertD performance and achieve the following goals:
Goal 1: Assess device performance in the “real world” in the intended use population.
Goal 2: Assess device performance across representative demographic subgroups.
Goal 3: Assess impact of device results on healthcare provider (HCP) prescribing practices.
Goal 4: Assess patient and HCP comprehension of the device labeling.
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| Study Population |
Patients who are prescribed AvertD as part of their clinical care prior to being prescribed a first prescription of oral opioids for 4-30 days for acute
pain management.
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| Sample Size |
A minimum of 3000 subjects targeting the identification of a minimum of 50 OUD positive subjects each in White, African-American, Other Racial
Subgroups, and Hispanic/Latino racial and ethnic subgroups.
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| Key Study Endpoints |
The Primary Endpoints for the AvertD PAS for each Goal are described below:
Goal 1: Sensitivity and specificity of AvertD in the overall study population
Goal 2: Sensitivity and specificity of AvertD in the representative demographic subgroups
Goal 3: Difference, if any, in HCPs’ opioid prescribing practices for the patient prior to and after receiving AvertD test results
Goal 4: The percentage of correct responses for participants and for HCPs on a knowledge test
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| Follow-up Visits and Length of Follow-up |
One virtual study visit is planned for after subject enrollment and baseline assessment, but before the subject’s procedure for which they were
provided an opioid prescription. This visit is intended to record the AvertD test results and the details of the planned procedure as well as record the
HCP’s Opioid prescription details after receipt of the AvertD test results.
One virtual follow-up is planned ~14 days after the patient’s procedure to confirm if the patient filled their opioid prescription and used the opioids as
instructed. An optional second follow-up is available ~30 days after the patient’s procedure for subjects who had not fill or take opioids at the time
of the first 14 day follow up.
For the next 5 years, patients will be assessed annually each year (remotely) using the M.I.N.I. Questionnaire following the DSM 5 criteria to determine if the participant has developed OUD.
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