Post-Market Clinical Follow-up of Patients With CODMAN CERTAS Plus Programmable Valve
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 158
- 试验地点
- 9
- 主要终点
- Precise Device Placement: Maintaining Integrity and Functionality at 30 Days Post-Deployment
研究概览
简要总结
Post-Market Clinical Follow-up Registry of Patients with CODMAN CERTAS Plus Programmable Valves.
详细描述
The CODMAN CERTAS Plus Programmable Valve is a single use implantable device designed for shunting cerebrospinal fluid (CSF) for the treatment of hydrocephalus.
The valve can be set to 8 different performance settings for intraventricular pressure and drainage of CSF. The performance setting of the valve can be set preoperatively and can also be noninvasively changed post-implantation.
This clinical investigation will maintain data for each patient from the date of implant through 3 years post-implantation.
Data collection for each patient will occur per standard of care.
However, the clinical investigation specifically aims to collect and analyze data from the day of procedure, and post-operatively at 1 month, 3 months, 6 months, 12 months, 24 months, and 36 months.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient and/or legally authorized representative has agreed to participate in the study by signing the EC-approved consent form, where applicable.
- •Patients (of any age) who underwent or who plan to have a surgical procedure utilizing one of the Codman CERTAS Plus Programmable Valves.
- •Patient (legally designated representative) is willing to comply with the study protocol timelines & requirements.
- •For patients who have had the Codman CERTAS Plus Programmable Valve implanted prior to study enrollment, have available data from implantation to the current time.
排除标准
- •Patients undergoing implantation of the CODMAN CERTAS Plus Programmable Valve as a revision procedure.
- •Patient's planned shunt has distal drainage to the heart.
- •Patient has ventriculitis, peritonitis or meningitis.
- •Patient has sepsis.
- •Patient has a history of poor wound healing.
- •Patient has symptoms pertaining to a skin infection at or near the site of any incisions; an ear infection on either side; a respiratory tract infection; or a urinary tract infection that, in the Investigator's opinion is clinically significant and might compromise the outcome of this study.
- •Patient has had any form of bowel surgery 30 days prior to device implant or anticipates bowel surgery within 90 days following device implant.
- •Patient is otherwise determined by the Investigator to be medically unsuitable for participation in this study.
- •Patient is currently enrolled in another drug or device trial or has been previously entered in this trial.
- •Patient is a prisoner or member of a different vulnerable population that should not be included in the study per the investigator.
- •Patients with known hypersensitivity to rifampin or clindamycin hydrochloride. This criterion applies for patients to be treated with the BACTISEAL Catheters (included in some models of the valve) only.
研究组 & 干预措施
CODMAN CERTAS Programmable Valves
CODMAN CERTAS Plus Programmable Valve, CODMAN CERTAS Plus Small Inline Programmable Valve, and CODMAN CERTAS Plus Right Angle Programmable Valve.
干预措施: CODMAN CERTAS Plus Programmable Valve (Device)
结局指标
主要结局
Precise Device Placement: Maintaining Integrity and Functionality at 30 Days Post-Deployment
时间窗: 30 Days
Device Success is defined as: 1. Deployment with the correct valve positioning 2. Original intended device in place, and 3. No additional surgical or interventional procedures related to access or the device since completion of the original procedure.
次要结局
未报告次要终点