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NCT01240356 · ClinicalTrials.gov registry record · Phase 1
CLOTBUST Hands-Free: A Phase I/II Pilot Safety Trial
A Phase 1 study, sponsored by The University of Texas Health Science Center, Houston.
- Completed
- Registry status
- Phase 1
- Development phase
- 35
- Enrollment target
NCT01240356: Completed Phase 1 study, sponsored by The University of Texas Health Science Center, Houston.
NCT01240356 is a Phase 1 study that has completed, run by The University of Texas Health Science Center, Houston. The registered enrollment target is 35 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (42% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01240356, a Phase 1 study, has completed, sponsored by The University of Texas Health Science Center, Houston.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 35 participants
- Enrollment target
Study Summary
The purpose of CLOTBUST-HF is to determine the safety of a novel, external Hands-Free transcranial Doppler (TCD) ultrasound system in healthy volunteers and ischemic stroke patients. If found to be safe, the widespread use of operator-independent, ultrasound-enhanced thrombolysis will allow the planning for a large Phase III efficacy trial.
Primary Outcome
Phase I : Imaging of the brain via MRI scans was performed to determine if the Hands-Free transcranial Doppler (TCD) system results in any BBB-disruption or deterioration in permeability.
Interventions
- DEVICE 2-MHz transcranial Doppler ultrasound
- DEVICE 2-MHz transcranial Doppler ultrasound insonation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 2008-12 |
| Est. Completion | 2013-10 |
| Phase | Phase 1 |
What the finished NCT01240356 record still lists
NCT01240356 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 35 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (42% lower).
The record links to 0 conditions, and to 2 interventions - of which 2-MHz transcranial Doppler ultrasound is the first listed.
NCT01240356 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01240356 about?
NCT01240356 is a clinical study titled "CLOTBUST Hands-Free: A Phase I/II Pilot Safety Trial". The purpose of CLOTBUST-HF is to determine the safety of a novel, external Hands-Free transcranial Doppler (TCD) ultrasound system in healthy volunteers and ischemic stroke patients. If found to be safe, the widespread use of operator-independent, ultrasound-enhanced thrombolysis will allow the plan...
What is the current status of trial NCT01240356?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 35 participants. The study started on 2008-12. Estimated completion is 2013-10.
What interventions are being tested in trial NCT01240356?
The interventions under investigation include: 2-MHz transcranial Doppler ultrasound (DEVICE), 2-MHz transcranial Doppler ultrasound insonation (DEVICE).
Who is sponsoring clinical trial NCT01240356?
This trial is sponsored by The University of Texas Health Science Center, Houston, which has 732 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01240356's enrollment target sits among peer trials
35 1258th of 2000 higher than 728 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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