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

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



Sponsors

Lead Sponsor



Source

[Redacted]

Overall Status

Withheld

Start Date

2014-10-09

Completion Date

N/A

Primary Completion Date

N/A

Phase

N/A

Study Type

N/A

Condition

 

Verification Date

N/A

Lastchanged Date

2017-07-13

Firstreceived Date

2017-07-13

Responsible Party

Name Title

[Redacted]

Organization

[Redacted]


Firstreceived Results Date

N/A

Firstreceived Results Disposition Date

N/A


ClinicalTrials.gov processed this data on July 17, 2017

Conditions

Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov, conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions

Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied. Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase

Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions that study is seeking to answer:

In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.

In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.

In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.

In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.

These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.



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