Prospective Observational Study of the Power PICC Family of Devices and Accessories
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 450
- 试验地点
- 14
- 主要终点
- Primary Safety: Incidence of Symptomatic Venous Thrombosis in Patients With a Device From the BD PowerPICC Family Used for Both Short- and Long-term Venous Access.
研究概览
简要总结
Post-market, observational study to collect prospective data related to the safety and performance of the Power PICC family of devices and its accessories in a real-world setting.
详细描述
Single-arm, post-market, observational, prospective study to asses the safety and performance of the Power PICC Power PICC family of devices and its accessories in a real-world setting. The study will only enroll patients that need a Power PICC catheter as part of their medical care. Patients will be followed from insertion through removal, or up to 180 days (whichever comes first). Data collected will be gathered from the patient's medical chart.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Any patient, regardless of age or gender, for which the investigator has decided that one of the PowerPICC study devices for either short-or long-term venous access should be inserted as standard of care
- •Expected to be available for observation through the duration of PICC therapy (including outpatient therapy, if applicable)
- •Provision of signed and dated informed consent form (Note: Consent of guardian or parent may be required for patients under the age of 18 years; participant assent may be required as well.)
排除标准
- •Presence of any device-related infection, bacteremia, or septicemia is known or suspected
- •Body size is insufficient to accommodate the size of implanted device
- •Known or suspected to be allergic to materials contained in the device
- •History of irradiation of prospective insertion site
- •Previous episode(s) of venous thrombosis or vascular surgical procedures at the prospective placement site
- •Local tissue factors which would prevent proper device stabilization and/or access
结局指标
主要结局
Primary Safety: Incidence of Symptomatic Venous Thrombosis in Patients With a Device From the BD PowerPICC Family Used for Both Short- and Long-term Venous Access.
时间窗: from insertion though removal or 180 days, whichever comes first
Incidence of symptomatic venous thrombosis defined as any new occurrence of symptomatic venous thrombosis defined by thrombus presence by ultrasonography or other imaging.
Primary Performance: Percent of PICCs That Remain in Place Through the Required Therapy Time Period.
时间窗: from insertion though removal or 180 days, whichever comes first
PICCs remaining in place through the required therapy time period were defined as PICCs that were either still in place at the end of the 180-day observation or had been removed because the therapy was completed (end of useful medical use), changed or cancelled. Most patients who died during the study had the device still in place at the time of death and hence were considered as having completed the therapy.
次要结局
- Secondary Safety: Incidence of Catheter-related Bloodstream Infection.(from insertion though removal or 180 days, whichever comes first)
- Secondary Safety: Incidence of Accidental Dislodgement.(from insertion though removal or 180 days, whichever comes first)
- Secondary Safety: Incidence of Vessel Laceration.(from insertion though removal or 180 days, whichever comes first)
- Secondary Safety: Incidence of Phlebitis(from insertion though removal or 180 days, whichever comes first)
- Secondary Safety: Incidence of Local Infection(from insertion though removal or 180 days, whichever comes first)
- Secondary Performance: Percent of Patent Catheters(from insertion though removal or 180 days, whichever comes first)
- Secondary Performance - Usability: Ease of Insertion(during the insertion procedure)
- Secondary Safety: Incidence of Vessel Perforation.(from insertion though removal or 180 days, whichever comes first)
- Secondary Safety: Incidence of Extravasation(from insertion though removal or 180 days, whichever comes first)
- Secondary Safety: Incidence of Local Infection as Presence of Pus at the Exit Site and/or Culture Confirmed Site Infection(from insertion though removal or 180 days, whichever comes first)
- Secondary Performance: Percent of Placement Success in Single Insertion Attempt(during the insertion procedure)