NCT06056739招募中不适用
Alio WEAR Study: Long-term Wear of the Alio Platform
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Alio, Inc.
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Assessing usage of the Alio platform by the test subject
研究概览
简要总结
The WEAR study is long-term interventional study designed to evaluate patient and clinician use of the Alio platform, per its FDA cleared indications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 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
- •At least 18 years of age.
- •Receiving hemodialysis via an AVF or AVG in an arm location at the time of study start.
- •Able to wear the SmartPatch effectively at the specified location on the arm.
- •Ability to understand and sign a written informed consent form, which must be obtained prior to initiation of any study procedures.
- •Willing and able to wear the SmartPatch as instructed and comply with all interviews, surveys and questionnaires, and schedule of evaluations.
排除标准
- •Skin near the proximity of the AV access that is chronically swollen, infected, inflamed, open wounds, lesions, or has skin eruptions.
- •Participation in any other clinical trials involving investigational or marketed products that in the opinion of the investigator could affect the quality of the data.
- •Other conditions that in the opinion of the Principal Investigator may increase risk to the subject and/or compromise the quality of the clinical trial.
研究组 & 干预措施
Test Subject
Experimental
All subjects who are enrolled into the test group and participate in data collection receive the noninvasive Alio platform.
干预措施: Alio platform (Device)
Control Subject
No Intervention
All subjects who are enrolled into the control group and participate in data collection will not receive the noninvasive Alio platform.
结局指标
主要结局
Assessing usage of the Alio platform by the test subject
时间窗: Up to 1 year
Assessing compliance and ease of use via surveys
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
已完成
不适用
Investigational Extended Wear Insulin Infusion Set in People With Type 1 DiabetesType1diabetesNCT06273124Tandem Diabetes Care, Inc.260
招募中
不适用
Prospective Longitudinal Study of Heylo™ for People Living With a StomaStoma IleostomyNCT06554015Coloplast A/S100
已完成
不适用
AIR2 Extension Study to Demonstrate Longer-term (> 1 Year) Durability of EffectivenessAsthmaNCT01350414Boston Scientific Corporation181
已完成
不适用
An Evaluation of the Long-Term Impact of Assistive AI on Anaesthetists' Ultrasound Scanning for UGRAUltrasound Imaging of Anatomical StructuresNCT05583032IntelligentUltrasound Limited58
已完成
Unknown
Investigator-initiated Clinical Study of Wearable Assistive Robot for Lower Limbs Controlled Voluntarily by Bioelectric Signals etc.(Hybrid Assistive Limb [HAL]-HN01) as a New Medical Device to Delay Progression of Intractable Rare Neuromuscular Diseases-Randomized, Controlled, Crossover Study for Gait Improvement as a Short-Term Effect (Study NCY-3001)JPRN-jRCT2092220156Takashi Nakajima30