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NCT04417088 · ClinicalTrials.gov registry record · Phase 1
Exablate Blood-Brain Barrier Disruption for the Treatment of rGBM in Subjects Undergoing Carboplatin Monotherapy
A Phase 1 study, sponsored by InSightec.
- Completed
- Registry status
- Phase 1
- Development phase
- 28
- Enrollment target
NCT04417088: Completed Phase 1 study, sponsored by InSightec.
NCT04417088 is a Phase 1 study that has completed, run by InSightec. The registered enrollment target is 28 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (53% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04417088, a Phase 1 study, has completed, sponsored by InSightec.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 28 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the safety and feasibility of the Exablate Model 4000 Type 2 system when used as a tool to open the blood-brain-barrier (BBB) in subjects with recurrent glioblastoma (rGBM) undergoing carboplatin monotherapy.
Primary Outcome
All adverse events and/or Serious Adverse Events will be documented and reported according to CTCAE criteria.
Interventions
- DRUG Carboplatin
- DEVICE Exablate BBBD
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2020-11-06 |
| Est. Completion | 2023-12-31 |
| Phase | Phase 1 |
What the finished NCT04417088 record still lists
NCT04417088 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 28 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (53% lower).
The record links to 0 conditions, and to 2 interventions - of which Carboplatin is the first listed.
NCT04417088 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04417088 about?
NCT04417088 is a clinical study titled "Exablate Blood-Brain Barrier Disruption for the Treatment of rGBM in Subjects Undergoing Carboplatin Monotherapy". The purpose of this study is to evaluate the safety and feasibility of the Exablate Model 4000 Type 2 system when used as a tool to open the blood-brain-barrier (BBB) in subjects with recurrent glioblastoma (rGBM) undergoing carboplatin monotherapy.
What is the current status of trial NCT04417088?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 28 participants. The study started on 2020-11-06. Estimated completion is 2023-12-31.
What interventions are being tested in trial NCT04417088?
The interventions under investigation include: Carboplatin (DRUG), Exablate BBBD (DEVICE).
Who is sponsoring clinical trial NCT04417088?
This trial is sponsored by InSightec, which has 38 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04417088's enrollment target sits among peer trials
28 1447th of 2000 higher than 538 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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