X-Ray Verified Accuracy of the proGAV Verification Instrument
Completed
- Conditions
- Hydrocephalus Shunt (proGAV) Requiring Adjustment
- Registration Number
- NCT01885468
- Lead Sponsor
- Aesculap, Inc.
- Brief Summary
This study is to verify the use of a hand held tool to verify the new setting of a hydrocephalus shunt (proGAV). This tool would be used in place of an Xray of the patient's head, which is how settings are verified currently.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 12
Inclusion Criteria
- Implanted with proGAV Requiring adjustment Implant must be palpable under the skin
Exclusion Criteria
- Unwilling to consent Implanted within 7 days of inclusion visit
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Level of agreement between the proGAV® verification instrument measurement and X-ray control measurements. 1day
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
Valley Children's Hospital
🇺🇸Madeira, California, United States
Geisinger Medical Center
🇺🇸Danville, Pennsylvania, United States