Phase 3
N=274
A Precision and Accuracy Study of the Codman Valve Position Verification (VPV) System.
Hydrocephalus · Normal Pressure Hydrocephalus
Bottom Line
View on ClinicalTrials.gov: NCT00196196 ↗Enrolled (actual)
274
Serious AEs
—
Results posted
Dec 2008
Primary outcome: Primary: Percentage of Participants Who Achieved "Adjustment Complete" and a Consensus X-ray Reading — 98.33 Percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Codman VPV System (Device)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Codman & Shurtleff
- Primary completion
- Oct 2006
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Who Achieved "Adjustment Complete" and a Consensus X-ray Reading |
98.33 | — |
| SECONDARY Percentage of Agreement Between the Codman Valve Position Verification (VPV) System and Consensus X-rays Using Various Thresholds |
63.89; 96.11; 1.67 | — |
Summary
The purpose of this study is to determine the agreement rate between the CODMAN Valve Position Verification (VPV) adjustment outcome (reprogramming) and X-ray verification in order to support an alternative to X-ray confirmation with respect to the valve adjustment process.
Eligibility Criteria
Inclusion Criteria
- A CODMAN Hakim Programmable Valve (CHPV) has been implanted for the management of the Subject's Hydrocephalus.
- The Subject has given written informed consent prior to enrolling in the study.
- The Subject requires adjustment of the CODMAN Hakim Programmable Valve (CHPV) for the management of Hydrocephalus·
- The Subject's implanted CHPV will be adjusted using the Implanted Valve Mode.
Exclusion Criteria
- The Subject's valve is located in the deep lumbar position.
- The Subject has an open and/or recent wound site in the region of the implanted valve.
- The Subject has a history of Ultrasound gel allergies.
- The Subject is a prisoner.
- The subject has been previously enrolled in this protocol.
Data sourced from ClinicalTrials.gov (NCT00196196). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.