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Recruiting Observational

AvertD Post-Approval Study

NCT07135323 · tracked via the Priya Life Science USA tracker
Sponsor
Prescient Medicine Holdings, Inc
Phase
Observational
Started
2024-11-15
Last updated
2025-08-22

Condition(s) studied

Opioid Use Disorder

Investigational drug(s) / intervention(s)

Opioid Used Disorder Risk Assessment

Opioid Used Disorder Risk Assessment: Determine the likelihood of Opioid Used Disorder prior to prescribing opioids

Study summary

A Prospective Post-Approval Study of AvertD to Evaluate Device Performance, Prescribing Impact, and Labeling Comprehension in the Intended Use Population

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
Inclusion Criteria: * ≥18 years of age * Prior to first opioid prescription * Being considered for first oral opioid prescription (4-30 days) * Prescribed AvertD as part of care * Willing and able to complete yearly assessments for 5 years * Signed informed consent Exclusion Criteria: * Planned opioid prescription \<4 or \>30 days * Any condition making participation unsafe or infeasible per investigator judgment

Primary outcome measure(s)

  • Sensitivity and Specificity of AvertD — Measured over 5 years
    Comparison of Averted results to diagnosis of Opioid Used Disorder from M.I.N.I. tool

Trial sites (1)

FacilityCityRegionStatus
Concentrics Research Indianapolis Indiana Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07135323 on ClinicalTrials.gov ↗ ← All trials in the USA