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

StatusRecruiting
PhaseNot applicable
SponsorInSightec
Started
View on ClinicalTrials.gov ↗

Record History

  1. Site contacts updated at 2 of 4 sitesv17
  2. Primary completion date: Dec 31, 2025 to Dec 31, 2026 Completion date: Dec 31, 2026 to Dec 31, 2027 · Site contacts updated at 2 of 4 sitesv16 Show 2 more changesShow less
    • Completion date: Dec 31, 2026 to Dec 31, 2027
    • Site contacts updated at 2 of 4 sites
  3. Site details revised at 1 of 4 sitesv15
  4. Site details revised at 3 of 4 sitesv14
  5. Study sites: 3 to 4v13
Show 11 earlier versionsHide 11 earlier versions
  1. Study sites: 2 to 3v12
  2. Re-verified, no change to tracked fieldsv11
  3. Primary completion date: Dec 31, 2024 to Dec 31, 2025 Enrollment target: 23 to 29 · Study sites: 1 to 2 · Completion date: Jul 2025 to Dec 31, 2026 · 1 morev10 Show 4 more changesShow less
    • Enrollment target: 23 to 29
    • Study sites: 1 to 2
    • Completion date: Jul 2025 to Dec 31, 2026
    • Study title expanded, about 6 words

    See this version in full on ClinicalTrials.gov ↗

  4. Primary completion date: Dec 2023 to Dec 31, 2024 Completion date: Jul 2024 to Jul 2025v9 Show 1 more changeShow less
    • Completion date: Jul 2024 to Jul 2025
  5. Enrollment target: 8 to 23 Eligibility criteria expanded, about 548 words · Site contact updatedv8 Show 2 more changesShow less
    • Eligibility criteria expanded, about 548 words
    • Site contact updated

    See this version in full on ClinicalTrials.gov ↗

  6. Trial status: Active, Not Recruiting to Recruiting Enrollment target: 4 to 8 · Primary completion date: Dec 2022 to Dec 2023 · Completion date: Dec 2023 to Jul 2024 · 1 morev7 Show 4 more changesShow less
    • Enrollment target: 4 to 8
    • Primary completion date: Dec 2022 to Dec 2023
    • Completion date: Dec 2023 to Jul 2024
    • Site details revised
  7. Primary completion date: Jan 2022 to Dec 2022 Completion date: Jul 2022 to Dec 2023v6 Show 1 more changeShow less
    • Completion date: Jul 2022 to Dec 2023
  8. Trial status: Recruiting to Active, Not Recruiting Primary completion date: Nov 2021 to Jan 2022 · Completion date: Nov 2021 to Jul 2022 · Site details revisedv5 Show 3 more changesShow less
    • Primary completion date: Nov 2021 to Jan 2022
    • Completion date: Nov 2021 to Jul 2022
    • Site details revised
  9. 3 versions Re-verified since Apr 10, 2020, no change to tracked fieldsv2-v4
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
InSightec
42 trials monitored
See 1 trial at risk
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.
Trial Details
NCT Number NCT04197921
Lead Sponsor InSightec
Conditions Opioid-use Disorder, Substance Use Disorders
Enrollment 29 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov