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NCT04197921 · ClinicalTrials.gov record · last posted 2026-06-26

Exablate for LIFU Neuromodulation in Patients With Opioid Use Disorder (OUD) and/or Other Substance Use Disorders (SUDs)

StatusRecruiting
PhaseNot applicable
SponsorInSightec
Started2019-11-27
View on ClinicalTrials.gov ↗
from the ClinicalTrials.gov record
The purpose of this clinical trial is to investigate Low Intensity Focused Ultrasound (LIFU) using the Exablate® Model 4000 Type 2.0/2.1 as an adjunctive neuromodulatory treatment for OUD (Opioid Use Disorder) and/or other Substance Use Disorders (SUDs) by assessing its safety and tolerability in subjects with OUD.

Amendment record 16 amendments on the ClinicalTrials.gov record

This ClinicalTrials.gov record has been amended 16 times since 2019-12-11; most recent amendment 2026-06-24. DataLookout shows field-level changes from the day a trial enters its daily monitoring; earlier amendments are counted here from the ClinicalTrials.gov version history. See every version on ClinicalTrials.gov ↗

2023-02-03
Status change Active, Not Recruiting→Recruitingv6
2021-11-30
Status change Recruiting→Active, Not Recruitingv4
Trial Details
NCT Number NCT04197921
Lead Sponsor InSightec
Conditions Opioid-use Disorder, Substance Use Disorders
Enrollment 29 participants
Start Date 2019-11-27
Primary Completion 2026-12-31 (estimated)
Study Completion 2027-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-06-26