NCT01885468

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2013

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 21, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 25, 2013

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

January 27, 2017

Status Verified

January 1, 2017

Enrollment Period

3.1 years

First QC Date

June 21, 2013

Last Update Submit

January 26, 2017

Conditions

Hydrocephalus Shunt (proGAV) Requiring Adjustment

Keywords

Hydrocephalus shuntproGAV

Outcome Measures

Primary Outcomes (1)

  • Level of agreement between the proGAV® verification instrument measurement and X-ray control measurements.

    1day

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Hydrocephalus patients implanted with proGAV shunt requiring adjustment

You may qualify if:

  • Implanted with proGAV Requiring adjustment Implant must be palpable under the skin

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Valley Children's Hospital

Madeira, California, 93636-8762, United States

Location

Geisinger Medical Center

Danville, Pennsylvania, 17822, United States

Location

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 21, 2013

First Posted

June 25, 2013

Study Start

May 1, 2013

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

January 27, 2017

Record last verified: 2017-01

Locations

US(2)