[Trial of device that is not approved or cleared by the U.S. FDA]
- Registration Number
- NCT00942942
- Lead Sponsor
- [Redacted]
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHHELD
- Sex
- Not specified
- Target Recruitment
- Not specified
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- Not specified
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Related Research Topics
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What molecular mechanisms underlie the device's therapeutic effects in unapproved medical applications?
How does the investigational device compare to FDA-cleared alternatives in treating similar conditions?
Are there specific biomarkers that predict optimal patient selection for this unapproved device therapy?
What adverse events have been reported in trials of similar non-FDA approved medical devices and how are they managed?
What are the current regulatory challenges for devices like NCT00942942 in transitioning from investigational to approved status?