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NCT00196196 · ClinicalTrials.gov registry record · Phase 3
A Precision and Accuracy Study of the Codman Valve Position Verification (VPV) System.
A Phase 3 study, sponsored by Codman & Shurtleff.
- Completed
- Registry status
- Phase 3
- Development phase
- 274
- Enrollment target
NCT00196196: Completed Phase 3 study, sponsored by Codman & Shurtleff.
NCT00196196 is a Phase 3 study that has completed, run by Codman & Shurtleff. The registered enrollment target is 274 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (65% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00196196, a Phase 3 study, has completed, sponsored by Codman & Shurtleff.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 274 participants
- Enrollment target
Study 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.
Primary Outcome
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".
Interventions
- DEVICE Codman VPV System
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 274 participants |
| Start Date | 2004-09 |
| Est. Completion | 2006-10 |
| Phase | Phase 3 |
What the finished NCT00196196 record still lists
NCT00196196 is an interventional study that assigns participants to a tested intervention. The registered 274 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (65% lower).
The record links to 0 conditions, and to 1 intervention - of which Codman VPV System is the first listed.
NCT00196196 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00196196 about?
NCT00196196 is a clinical study titled "A Precision and Accuracy Study of the Codman Valve Position Verification (VPV) System.". 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.
What is the current status of trial NCT00196196?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 274 participants. The study started on 2004-09. Estimated completion is 2006-10.
What interventions are being tested in trial NCT00196196?
The interventions under investigation include: Codman VPV System (DEVICE).
Who is sponsoring clinical trial NCT00196196?
This trial is sponsored by Codman & Shurtleff, which has 6 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00196196's enrollment target sits among peer trials
274 1207th of 2000 higher than 788 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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