[Trial of device that is not approved or cleared by the U.S. FDA]
Sponsor:
[Redacted]
Collaborators:
Information provided by (Responsible Party):
,
| Tracking Information | |||
|---|---|---|---|
| First Submitted Date ICMJE | October 3, 2018 | ||
| First Posted Date ICMJE | October 4, 2018 | ||
| Last Update Posted Date | October 4, 2018 | ||
| Actual Study Start Date ICMJE | |||
| Estimated Primary Completion Date | (Final data collection date for primary outcome measure) | ||
| Current Primary Outcome Measures ICMJE |
[ Time Frame: ] |
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| Original Primary Outcome Measures ICMJE | Same as current | ||
| Current Secondary Outcome Measures ICMJE |
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| Descriptive Information | |||
| Brief Title ICMJE | [Trial of device that is not approved or cleared by the U.S. FDA] |
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| Official Title ICMJE | [Trial of device that is not approved or cleared by the U.S. FDA] |
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| Brief Summary | |||
| Detailed Description | |||
| Study Type ICMJE | N/A | ||
| Study Phase | |||
| Study Design ICMJE | Allocation: Intervention Model: Intervention Model Description: Masking: N/A Masking Description: Primary Purpose: |
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| Condition ICMJE | |||
| Intervention ICMJE |
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| Study Arms |
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| Recruitment Information | |||
| Recruitment Status ICMJE | Withheld | ||
| Estimated Enrollment ICMJE |
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| Original Estimated Enrollment ICMJE | Same as current | ||
| Estimated Study Completion Date | |||
| Estimated Primary Completion Date | (Final data collection date for primary outcome measure) | ||
| Eligibility Criteria ICMJE | |||
| Sex/Gender |
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| Ages | and older (Adult, Older Adult) | ||
| Accepts Healthy Volunteers | No | ||
| Listed Location Countries ICMJE | |||
| Removed Location Countries | |||
| Administrative Information | Has Data Monitoring Committee | ||
| U.S. FDA-regulated Product |
Studies a U.S. FDA-regulated Drug Product: Studies a U.S. FDA-regulated Device Product: |
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| IPD Sharing Statement |
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| Responsible Party | , | ||
| Study Sponsor ICMJE | [Redacted] | ||
| Collaborators ICMJE | |||
| Investigators ICMJE |
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| PRS Account | |||
| Verification Date | |||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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