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Exablate for LIFU Neuromodulation in Patients With Opioid Use Disorder (OUD) and/or Other Substance Use Disorders (SUDs)
NCT04197921 · View on ClinicalTrials.gov ↗
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
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
| Field | Value |
|---|---|
| Enrollment Target | 29 participants |
| Start Date | 2019-11-27 |
| Est. Completion | 2027-12-31 |
| Phase | NA |
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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. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 29 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is InSightec, which has 76 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Substance Use Disorders appearing as the primary indexed condition, and to 1 intervention — of which Exablate Model 4000 Type 2.0/2.1 is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04197921 reports 4 study locations spanning 4 distinct geographic areas — top geographies include Florida, Maryland, New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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: Substance Use Disorders, Opioid-use Disorder. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04197921?
The interventions under investigation include: Exablate Model 4000 Type 2.0/2.1 (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04197921?
This trial is sponsored by InSightec, which has 76 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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