NCT04920929终止不适用
A Prospective, Randomized, PICC Asymptomatic Thrombosis Study: A Pilot Study
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Asymptomatic Thrombosis Rate
研究概览
简要总结
The study purpose is to perform a preliminary, comparative evaluation of the Hydrophilic Biomaterial technology to confirm the performance of the catheter, by using UltraSound technology in-vivo.
详细描述
This study will compare two different materials to evaluate asymptomatic thrombosis using ultrasound technology.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is indicated for a medically necessary PICC for therapeutic delivery medication
- •Patient is eligible to receive a single lumen PICC
- •Patient is an adult who is prescribed a PICC line
- •Patient's expected duration of treatment requiring a PICC for a minimum of 16 days post device implantation
- •Patient understands and is willing to comply with all study requirements and has voluntarily signed the Informed Consent Form (ICF).
排除标准
- •Is pregnant, lactating, or is planning to become pregnant during the time of the study
- •Has been previously enrolled in this post market clinical evaluation, or is participating in another clinical study that is contraindicative to the treatment or outcomes of this investigation
- •Venous thrombosis in any portion of the vein to be catheterized
- •Conditions that impede venous return from the extremity such as paralysis or lymphedema after mastectomy
- •Orthopedic or neurological conditions affecting the extremity
- •Anticipation or presence of dialysis grafts or other intraluminal devices, including pacemakers, within a month of patient enrollment start
- •Patients who are on anticoagulation therapy prior to the study (10-14 days). Note: (If patients are placed on anticoagulation (low dose) therapy while hospitalized, these patients are allowed.)
- •Patient has relinquished control of care to a guardian and/or facility
- •Patient has any significant medical or physical condition that, in the opinion of the PI, would make the subject unsuitable for participation in the post market clinical evaluation
- •Inability to complete the protocol in the opinion of the clinical staff due to safety or other reasons
研究组 & 干预措施
Hydrophilic BioMaterial
Active Comparator
Hydrophilic BioMaterial- HydroPICC
干预措施: Hydrophilic Biomaterial (Device)
Thermoplastic Polyurethane
Active Comparator
TPU- 4 French Single Lumen PowerPICC
干预措施: Thermoplastic Polyurethane (Device)
结局指标
主要结局
Asymptomatic Thrombosis Rate
时间窗: 7 days post insertion
Rate of asymptomatic thrombosis measured using ultrasound technology for each group
次要结局
- Symptomatic Thrombosis Rate(7 days post insertion)
- Symptomatic Thrombosis Rate(14 days post insertion)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
2 期
Bone Substitute in the Multi Traumatized Nasal Septum ReconstructionNasal SeptumNCT01234415University Hospital, Bordeaux26
尚未招募
不适用
Vascular Response of Orsiro vs. Xience Drug-Eluting Stents for Treating Coronary Bifurcation LesionsCoronary Artery DiseaseNCT05200637Chang Gung Memorial Hospital150
已完成
不适用
Clinical Study of Biosilicate Under Resin Composite Restorations in Caries Affected TeethDental CariesNCT02389569University of Sao Paulo66
尚未招募
不适用
Effect of the Superhydrophilic Surface of Lance CLEAR Implants on the Marginal Bone Loss and Survival in Diabetic and Non Diabetic PatientsDiabetesNCT05979246MIS Implant Technologies, Ltd40
Unknown
不适用
Comparison of Histology From a Mesh Sponge and Traditional Esophageal Biopsies in Children and Adolescents With EoEEosinophilic EsophagitisNCT05342168The Hospital for Sick Children30