NCT04714385已完成不适用
Product Surveillance Registry (PSR) - Targeted Drug Delivery (TDD) - SynchroMed II European Post-Market Clinical Follow-up (PMCF)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Medtronic
- 入组人数
- 209
- 试验地点
- 15
- 主要终点
- Pump accuracy
研究概览
简要总结
The purpose of this study is to provide continuing evaluation and reporting of safety and performance of the SynchroMed II Infusion System within its intended use. Data will support post-market surveillance obligations.
详细描述
This study was originally posted under NCT01524276 and now posted alone to adapt to new ISO regulation.
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 or legally authorized representative provides written authorization and/or consent per institution and geographical requirements
- •Patient has or is intended to receive or be treated with an eligible Medtronic product
- •Patient within enrollment window relative to therapy initiation or meets criteria for retrospective enrollment
- •The indication for implant meets approved indications
- •The patient can reasonably be expected to remain fully on label for a 48-month time period after implant
排除标准
- •Patient who is, or will be, inaccessible for follow-up
- •Patient with exclusion criteria required by local law
- •Patient is currently enrolled in or plans to enroll in any concurrent drug and/or device study that may confound results
- •There is no indication at enrollment (e.g., medical conditions, anticipated relocation, etc.) that the patient will be unable to complete 48 months of follow-up after implant
结局指标
主要结局
Pump accuracy
时间窗: 4 years
Demonstrate that the proportion of subjects treated as intended (p) with flow rate accuracy outside the interval of 0.75 to 1.25 (±25 percent) is \< 10 percent with 95 percent confidence at 4 years post implant.
次要结局
- Pump survival(4 years)
研究者
研究点 (15)
Loading locations...
相似试验
招募中
不适用
Product Surveillance RegistryCardiac Rhythm DisordersUrological DisordersNeurological DisordersCardiovascular DisordersDigestive DisordersMechanical Circulatory SupportRespiratory TherapyAortic, Peripheral Vascular and Venous DisordersMinimally Invasive Surgical ProceduresDiagnostic Techniques and ProceduresSurgical Procedures, OperativeNeurovascularEar, Nose and Throat DisorderRenal InsufficiencyCoronary Artery DiseaseIntracranial AneurysmNCT01524276Medtronic100,000
撤回
不适用
Product Surveillance Registry; Ear, Nose and Throat - EXTEND CohortChronic Rhinosinusitis (CRS)NCT06671561Medtronic100
已完成
不适用
A Post Market Study Evaluating the Safety, Device Perfomance and Possible Emergent Risks of Celotres in Preventing Recurrence in Keloid Lesions Treated Adjunctive to Surgical ExcisionEarlobe KeloidsNCT01706861Halscion, Inc.51
招募中
不适用
PANTHER Study of Terumo Aortic Knitted and Woven Grafts, and Cardiovascular PatchesDissectionAortic Root AneurysmAortic Root DissectionCarotid Artery InjuriesAortic ArchBypass Extremity GraftOcclusive Vascular DiseaseAortic DiseasesAneurysmNCT04545502Vascutek Ltd.2,000
终止
不适用
Surpass Flow Diverter for Intracranial Aneurysms: SURMOUNT Registry Data CollectionCerebral AneurysmNCT02281721Stryker Neurovascular150