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NCT04197921 · ClinicalTrials.gov registry record · NA

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

A NA study of Opioid Use Disorder and Substance Use Disorders, sponsored by InSightec.

Recruiting
Registry status
NA
Development phase
29
Enrollment target
4
Study locations

NCT04197921 is a NA study of Opioid Use Disorder and Substance Use Disorders that is actively recruiting participants, run by InSightec. The registered enrollment target is 29 participants, below the 4,656-participant average among 257 other Opioid Use Disorder trials with a reported enrollment target (99% lower). The trial reports 4 study locations across 4 states.

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The verdict

NCT04197921, a NA study of Opioid Use Disorder and Substance Use Disorders, is actively recruiting participants, sponsored by InSightec.

RECRUITING
Registry status
NA
Development phase
29 participants
Enrollment target
4
Study locations

Study Summary

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.

Conditions Studied

Opioid Use Disorder Substance Use Disorders

Interventions

  • DEVICE Exablate Model 4000 Type 2.0/2.1

Study Locations (4)

Florida

  • Tampa General Hospital - Tampa

Maryland

  • University of Maryland, Baltimore - Baltimore

New York

  • Weill Cornell Medicine - New York

West Virginia

  • West Virginia University: Rockefeller Neuroscience Institute - Morgantown

Trial Details

FieldValue
Enrollment Target 29 participants
Start Date 2019-11-27
Est. Completion 2027-12-31
Phase NA

Sponsor

InSightec

38 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04197921

The ClinicalTrials.gov registry entry for NCT04197921 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 29 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 4,656-participant average among 257 other Opioid Use Disorder trials with a reported enrollment target (99% lower). The listed sponsor is InSightec, which has 38 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Opioid Use Disorder appearing as the primary indexed condition, and to 1 intervention - of which Exablate Model 4000 Type 2.0/2.1 is the first listed.

NCT04197921 reports 4 study locations spanning 4 distinct geographic areas - top geographies include Florida, Maryland, New York.

Frequently Asked Questions

What is clinical trial NCT04197921 about?

NCT04197921 is a clinical study titled "Exablate for LIFU Neuromodulation in Patients With Opioid Use Disorder (OUD) and/or Other Substance Use Disorders (SUDs)". 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 su...

What is the current status of trial NCT04197921?

This trial is currently recruiting. It is a NA study. The enrollment target is 29 participants. The study started on 2019-11-27. Estimated completion is 2027-12-31.

What conditions does trial NCT04197921 study?

This clinical trial studies the following conditions: Opioid Use Disorder, Substance Use Disorders.

What interventions are being tested in trial NCT04197921?

The interventions under investigation include: Exablate Model 4000 Type 2.0/2.1 (DEVICE).

Who is sponsoring clinical trial NCT04197921?

This trial is sponsored by InSightec, which has 38 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04197921 being conducted?

This trial has 4 study locations across Florida, Maryland, New York, West Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.