X-Ray Verified Accuracy of the proGAV Verification Instrument

Hydrocephalus Shunt (proGAV) Requiring Adjustment Clinical Trial

— X-AMIN  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01885468
• Other study ID #: AAG-G-H-1106
• Status: Completed
• Phase: N/A
• First received: June 21, 2013
• Last updated: January 26, 2017
• Start date: May 2013
• Est. completion date: June 2016

Study information

• Verified date: January 2017
• Source: Aesculap, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Hydrocephalus
• Hydrocephalus Shunt (proGAV) Requiring Adjustment

Locations

Country	Name	City	State
United States	Geisinger Medical Center	Danville	Pennsylvania
United States	Valley Children's Hospital	Madeira	California

Sponsors (1)

Lead Sponsor	Collaborator
Aesculap, Inc.

Country where clinical trial is conducted

United States, 

Outcome

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