Trial · NCT00196196
A Precision and Accuracy Study of the Codman Valve Position Verification (VPV) System.
NCT00196196, Phase 3, Completed, Codman & Shurtleff; results first posted 2008-12-05
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Precision and Accuracy Study of the Codman Valve Position Verification (VPV) System. Trials, record NCT00196196. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00196196
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Precision and Accuracy Study of the Codman Valve Position Verification (VPV) System.
- NCT number
- NCT00196196
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 274 participants, actual
- Lead sponsor
- Codman & Shurtleff
- Conditions
- Hydrocephalus, Normal Pressure Hydrocephalus
- Interventions
- Codman VPV System
- First posted
- 2005-09-20
- Last updated
- 2012-05-28
- Results first posted
- 2008-12-05
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | 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) |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants Who Achieved Adjustment Complete and a Consensus X-ray Reading | Day 1 | Percentage of participants | NUMBER | |
| SECONDARY | Percentage of Agreement Between the Codman Valve Position Verification (VPV) System and Consensus X-rays Using Various Thresholds | Day 1 | Percentage of agreement | NUMBER |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants Who Achieved Adjustment Complete and a Consensus X-ray Reading | Codman VPV System | 98.33 | Percentage of participants | ||
| Percentage of Agreement Between the Codman Valve Position Verification (VPV) System and Consensus X-rays Using Various Thresholds | Codman VPV System | 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 | Codman VPV System | 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 | Codman VPV System | Percentage of Agreement >2 steps (>20 mmH20) | 1.67 | Percentage of agreement |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Codman VPV System | 274 | |
| Overall Study | COMPLETED | Codman VPV System | 267 | |
| Overall Study | NOT COMPLETED | Codman VPV System | 7 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Codman VPV System | ||
| Total, other adverse events | Codman VPV System | 0 | 0 |
| Total, serious adverse events | Codman VPV System | 0 | 0 |
Source ClinicalTrials.gov
Papers4
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00196196
GET https://conductscience.org/api/trials/v1/NCT00196196/registered