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[Trial of device that is not approved or cleared by the U.S. FDA]

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03897751
This trial has been identified as being associated with a clinical device that has not been approved or cleared by the US Food and Drug Administration. Under the terms of US Public Law 110-85, Title VIII, Section 801, the details of this study are not available to the public.
First Posted : April 1, 2019
Last Update Posted : October 4, 2019
Sponsor:
Information provided by:
[Redacted]

Tracking Information
First Submitted Date  ICMJE March 29, 2019
First Posted Date  ICMJE April 1, 2019
Last Update Posted Date October 4, 2019
Study Start Date  ICMJE Not Provided
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT03897751 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE [Trial of device that is not approved or cleared by the U.S. FDA]
Official Title  ICMJE [Trial of device that is not approved or cleared by the U.S. FDA]
Brief Summary Not Provided
Detailed Description Not Provided
Study Type  ICMJE Not Provided
Study Phase  ICMJE Not Provided
Study Design  ICMJE Not Provided
Condition  ICMJE Not Provided
Intervention  ICMJE Not Provided
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withheld
Enrollment  ICMJE Not Provided
Original Enrollment  ICMJE Not Provided
Study Completion Date  ICMJE Not Provided
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE Not Provided
Sex/Gender  ICMJE Not Provided
Ages  ICMJE Not Provided
Accepts Healthy Volunteers  ICMJE Not Provided
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03897751
Other Study ID Numbers  ICMJE 932
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party [Redacted]
Study Sponsor  ICMJE [Redacted]
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account [Redacted]
Verification Date Not Provided