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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: NCT03965039
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 : May 28, 2019
Last Update Posted : October 18, 2019
Sponsor:
Information provided by:
[Redacted]

Results Submitted - Quality Control (QC) Review Has Not Concluded
Results information for an applicable clinical trial (ACT) is posted within 30 days of submission even if the submission has not completed the ClinicalTrials.gov Results Quality Control (QC) review process. Results information is submitted to ClinicalTrials.gov by the sponsor or investigator, and National Library of Medicine (NLM) staff assess for apparent errors, deficiencies, or inconsistencies. NLM staff do not verify the scientific validity or relevance of the submitted information.

All versions of ACT results information submissions that have not completed the QC review process are posted on ClinicalTrials.gov (since January 2020). After the QC review process is completed, the results information is posted without QC review comments and previous versions are archived.

Recruitment Status : Withheld
Primary Completion Date : No date given
Study Completion Date : No date given
Submission Cycle Results Submitted to ClinicalTrials.gov Results Returned after Quality Control Review
1 October 1, 2020
October 23, 2020 Submission with QC Comments
2 October 26, 2020