Hydrocephalus, Normal Pressure Hydrocephalus
Conditions
Keywords
Hydrocephalus, Codman Hakim Programmable Valve, Programmable Valve, Shunt System
Brief 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.
Detailed description
Patients with Hydrocephalus, managed with an implanted Codman HakimTM Programmable Valve (CHPV), occasionally visit their physician to have their valve adjusted to a different setting to manage their condition. After the adjustment, an x-ray of the skull is taken to confirm the valve setting. The Codman VPV System is designed to facilitate and confirm the adjustment of a CHPV. After signing the informed consent, Subjects will be enrolled in the study and have their CHPV adjusted using the Codman VPV System. After the adjustment, an x-ray of the skull will be taken to verify the valve setting. No further follow up visit is needed after the adjustment. This study is expected to enroll about 300 Subjects from up to 20 sites in the United States.
Interventions
DEVICECodman VPV System
Valve Positioning Verification (VPV) System
Sponsors
Codman & Shurtleff
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Achieved Adjustment Complete and a Consensus X-ray Reading | Day 1 | Up to 5 attempts to achieve Adjustment Complete using the Codman Valve Position Verification (VPV) system for each Subject. Agreement in 2 of 3 valve X-ray readings by independent radiologists for each Subject was considered consensus X-ray. All participants included achieved Adjustment Complete and a consensus X-ray reading. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Agreement Between the Codman Valve Position Verification (VPV) System and Consensus X-rays Using Various Thresholds | Day 1 | Percentage of agreement between consensus X-ray readings and the intended setting programmed by the Codman Valve Position Verification (VPV) system. This was assessed at various steps (intervals of mmH20) as increments allow on the Codman Hakim Programmable Valve. (1 step = 10 mmH20, 2 steps = 20 mmH20, +2 steps = \>20 mmH20) |
Countries
United States
Participant flow
Recruitment details
Subjects were enrolled between September 29, 2004 and October 13, 2006. Twelve (12) investigational sites within the US enrolled 274 Subjects.
Pre-assignment details
Of the 274 Subjects enrolled, 5 were determined to be ineligible - did not have hydrocephalus, a required condition per inclusion/exclusion criteria. Two (2) Subjects withdrew early. Overall, 267 Subjects were eligible for analysis.
Participants by arm
| Arm | Count |
|---|---|
| Codman VPV System | 267 |
| Total | 267 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Did not have required condition (hydroce | 5 |
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | Codman VPV System |
|---|---|
| Age, Categorical <=18 years | 35 Participants |
| Age, Categorical >=65 years | 142 Participants |
| Age, Categorical Between 18 and 65 years | 90 Participants |
| Age Continuous | 57 years STANDARD_DEVIATION 26.1 |
| Region of Enrollment United States | 267 participants |
| Sex: Female, Male Female | 137 Participants |
| Sex: Female, Male Male | 130 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
Percentage of Participants Who Achieved Adjustment Complete and a Consensus X-ray Reading
Up to 5 attempts to achieve Adjustment Complete using the Codman Valve Position Verification (VPV) system for each Subject. Agreement in 2 of 3 valve X-ray readings by independent radiologists for each Subject was considered consensus X-ray. All participants included achieved Adjustment Complete and a consensus X-ray reading.
Time frame: Day 1
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Codman VPV System | Percentage of Participants Who Achieved Adjustment Complete and a Consensus X-ray Reading | 98.33 Percentage of participants |
Secondary
Percentage of Agreement Between the Codman Valve Position Verification (VPV) System and Consensus X-rays Using Various Thresholds
Percentage of agreement between consensus X-ray readings and the intended setting programmed by the Codman Valve Position Verification (VPV) system. This was assessed at various steps (intervals of mmH20) as increments allow on the Codman Hakim Programmable Valve. (1 step = 10 mmH20, 2 steps = 20 mmH20, +2 steps = \>20 mmH20)
Time frame: Day 1
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Codman VPV System | Percentage of Agreement Between the Codman Valve Position Verification (VPV) System and Consensus X-rays Using Various Thresholds | Percentage of Agreement (exact match) | 63.89 Percentage of agreement |
| Codman VPV System | Percentage of Agreement Between the Codman Valve Position Verification (VPV) System and Consensus X-rays Using Various Thresholds | Percentage of Agreement in 1 step (+/- 10 mmH20) | 96.11 Percentage of agreement |
| Codman VPV System | Percentage of Agreement Between the Codman Valve Position Verification (VPV) System and Consensus X-rays Using Various Thresholds | Percentage of Agreement >2 steps (>20 mmH20) | 1.67 Percentage of agreement |