Trials / Terminated
TerminatedNCT01490827
Argus® II Retinal Prosthesis System Post-Market Surveillance Study
- Status
- Terminated
- Phase
- —
- Study type
- Observational
- Enrollment
- 52 (actual)
- Sponsor
- Second Sight Medical Products · Industry
- Sex
- All
- Age
- 25 Years
- Healthy volunteers
- Not accepted
Summary
This post-market surveillance study is conducted in the European Economic Area where Argus II has been CE certified for use in outer retinal degeneration patients.
Detailed description
This study is being conducted to monitor the use of Argus II in a larger population than available within pre-market approval studies. Safety data will be monitored to ensure continued acceptability of risks to study participants, and an attempt will be made to include all eligible and willing participants implanted with Argus II. Measures of visual function that may contribute to device improvements will also be gathered and evaluated.
Conditions
Timeline
- Start date
- 2011-11-01
- Primary completion
- 2020-03-31
- Completion
- 2020-03-31
- First posted
- 2011-12-13
- Last updated
- 2020-05-21
Locations
10 sites across 2 countries: Germany, Italy
Source: ClinicalTrials.gov record NCT01490827. Inclusion in this directory is not an endorsement.