X-Ray Verified Accuracy of the proGAV Verification Instrument

X-Ray Verified Accuracy of the Aesculap - Miethke proGAV Adjustable Shunt Pressure Setting Verification Instrument

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01885468

Acronym

X-AMIN

Enrollment

Registered

2013-06-25

Start date

2013-05-31

Completion date

2016-06-30

Last updated

2017-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hydrocephalus Shunt (proGAV) Requiring Adjustment

Keywords

Hydrocephalus shunt, proGAV

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Level of agreement between the proGAV® verification instrument measurement and X-ray control measurements.	1day

Countries

United States

Outcome results