NCT07311733尚未招募不适用
Milky Way Sensor: Device Validation for Infiltrated Tissues
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- ivWatch, LLC
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- Red Notification Sensitivity to Infiltrated Tissues
研究概览
简要总结
A single arm trial consisting of 28 adult volunteers to assess the safety and efficacy of ivWatch sensors when observing infiltrated tissues at common sites for peripheral IV therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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
- 是
入选标准
- •18 years of age or older
- •Healthy, verified by an eligible designation on the Health History Form
排除标准
- •Abnormal bleeding / hemophilia
- •Absence of sensation in one or both arms
- •Allergy to common medical materials
- •Blood clotting disorder
- •Currently enrolled in another clinical trial
- •Current hepatitis infection or any history of hepatitis B or C
- •Currently pregnant
- •Daily regimen of blood thinning medication (e.g., aspirin, ibuprofen, naproxen, Coumadin®/warfarin, Eliquis®/apixaban).
- •Fever at the time of study visit (≥100.4°F)
- •Frequent dizziness or fainting spells, especially with needles
- •History of chronic, severe anemia
- •History of stroke
- •HIV / Aids
- •Immune deficiency disorder
- •Lymphedema
- •Major surgery or scar tissue which would complicate PIV access
- •Needle phobia
- •Radiation / chemotherapy in the last year
- •Received IV therapy in 14 days prior to study visit
- •Severe dehydration on day of study visit
- •Sick or had an infection in 14 days prior to study visit
- •Tattoo(s) that severely limits vein visualization at a sensor monitoring location
- •Unstable or uncontrolled cardiopulmonary disorder
- •Uncontrolled seizures
结局指标
主要结局
Red Notification Sensitivity to Infiltrated Tissues
时间窗: After each participant has been infiltrated, an expected average of 1 hour.
The ratio of the number of infiltrated IV sites where the ivWatch Model 400 device issued a red notification to the total number of infiltrated IV sites in the study. All infiltrations were limited to 10 mL of isotonic saline solution.
次要结局
- Yellow Notification Sensitivity to Infiltrated Tissues(After each participant has been infiltrated, an expected average of 1 hour.)
- Significant Skin Irritation or Disruption to Skin Integrity(After each participant has been infiltrated, an expected average of 1 hour.)
研究者
研究点 (2)
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