Trial Outcomes & Findings for A Precision and Accuracy Study of the Codman Valve Position Verification (VPV) System. (NCT NCT00196196)
NCT ID: NCT00196196
Last Updated: 2012-05-28
Results Overview
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".
COMPLETED
PHASE3
274 participants
Day 1
2012-05-28
Participant Flow
Subjects were enrolled between September 29, 2004 and October 13, 2006. Twelve (12) investigational sites within the US enrolled 274 Subjects.
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.
Participant milestones
| Measure |
Codman VPV System
|
|---|---|
|
Overall Study
STARTED
|
274
|
|
Overall Study
COMPLETED
|
267
|
|
Overall Study
NOT COMPLETED
|
7
|
Reasons for withdrawal
| Measure |
Codman VPV System
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
|
Overall Study
Did not have required condition (hydroce
|
5
|
Baseline Characteristics
A Precision and Accuracy Study of the Codman Valve Position Verification (VPV) System.
Baseline characteristics by cohort
| Measure |
Codman VPV System
n=267 Participants
|
|---|---|
|
Age, Categorical
<=18 years
|
35 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
90 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
142 Participants
n=5 Participants
|
|
Age Continuous
|
57 years
STANDARD_DEVIATION 26.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
137 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
130 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
267 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1Up 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".
Outcome measures
| Measure |
Codman VPV System
n=267 Participants
|
|---|---|
|
Percentage of Participants Who Achieved "Adjustment Complete" and a Consensus X-ray Reading
|
98.33 Percentage of participants
|
SECONDARY outcome
Timeframe: Day 1Percentage 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)
Outcome measures
| Measure |
Codman VPV System
n=267 Participants
|
|---|---|
|
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
|
|
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
|
|
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
|
Adverse Events
Codman VPV System
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60