Cochlear Implant PDA Based Research Platform (ciPDA)
|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: NCT01620385|
Recruitment Status : Unknown
Verified June 2012 by Philip Loizou, The University of Texas at Dallas.
Recruitment status was: Recruiting
First Posted : June 15, 2012
Last Update Posted : June 15, 2012
|Condition or disease||Intervention/treatment||Phase|
|Hearing Impaired||Device: ciPDA||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Multi Center Clinical Study to Assess the Safety of the UTD Cochlear Implant PDA (ciPDA) REsearch Platform|
|Study Start Date :||June 2011|
|Estimated Primary Completion Date :||June 2013|
|Estimated Study Completion Date :||June 2013|
The ciPDA Research Platform device was designed as a research tool for cochlear implant research.
Other Name: Single arm study.
- The objective of this study is to assess the safety of the PDA device after long-term use. Safety shall be measured by the adverse events reported in this study and compared to the study results reported in the clinical study for the PMA'd device. [ Time Frame: 5 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01620385
|Contact: Philip Loizou, PhDemail@example.com|
|United States, Texas|
|University of Texas - Dallas||Recruiting|
|Richardson, Texas, United States, 75083|
|Principal Investigator:||Philip Loizou, PhD||The University of Texas at Dallas|