NCT Number: NCT01885468
X-Ray Verified Accuracy of the proGAV Verification Instrument
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.
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Notify MeKey information
Sex eligibility
All sexes
Study type
Observational
Primary location
Valley Children's Hospital, Madeira, California, United States
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Primary outcomes
-
Level of agreement between the proGAV® verification instrument measurement and X-ray control measurements.
Time frame: 1day
Sponsors and collaborators
Lead sponsor
Aesculap, Inc.
Industry
Registry information
Official study title
X-Ray Verified Accuracy of the Aesculap - Miethke proGAV Adjustable Shunt Pressure Setting Verification Instrument
Acronym: X-AMIN
Important dates
- Study start
- 2013
- Primary completion
- 2016
- Study completion
- 2016
- First posted
- Jun 25, 2013
- Registry last updated
- Jan 27, 2017
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.