A Precision and Accuracy Study of the Codman Valve Position Verification (VPV) System.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 274
- 试验地点
- 8
- 主要终点
- Percentage of Participants Who Achieved "Adjustment Complete" and a Consensus X-ray Reading
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Percentage of Participants Who Achieved "Adjustment Complete" and a Consensus X-ray Reading
时间窗: 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".
次要结局
- Percentage of Agreement Between the Codman Valve Position Verification (VPV) System and Consensus X-rays Using Various Thresholds(Day 1)