Feasibility of Digital Thermal Monitoring to Assess Endothelium-Dependent Vasodilation in Patients Undergoing Hematopoietic Cell Transplantation (HCT)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 27
- 试验地点
- 2
- 主要终点
- The use of VENDYS-II in children and AYA as a measure of vascular endothelial function.
研究概览
简要总结
The Vendys II, an FDA-approved device, uses finger digital thermal monitoring (DTM) after a period of blood flow restriction to evaluate vascular health. This study will evaluate the feasibility of using this device to measure the Vascular Reactivity Index (VRI) in children and adolescents/young adults (AYA) undergoing hematopoietic cell transplantation (HCT).
详细描述
Primary Objective:
-Assess the feasibility of the use of VENDYS-II in children and AYA as a measure of vascular endothelial function, where feasibility is defined as completion of the evaluation by at least 70% of consented participants.
Secondary Objective:
-Summarize the incidence of any adverse events that precludes completion of assessment of endothelium-dependent vasodilation using the Vendys II in children and AYA.
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
- 6 Years 至 26 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •for HCT candidates:
- •Children, adolescents and young adults (AYA) 6-26 years of age who are HCT candidates
- •Recipients within 30 days prior to or within 14 days after autologous and allogeneic HCT.
- •. Any preparative regimen.
- •Willing and eligible to enroll on PA19-0756
- •Inclusion Criteria for Healthy Donors:
- •- Healthy HCT donors between the ages of 6-26 years of age.
排除标准
- •Any subject who does not consent/assent to participation.
- •. Any subject with an injury or deformation to the index finger which prevents proper fit of the device.
- •Any subject with skin toxicity or neuropathy which prevents comfortable use of the device.
研究组 & 干预措施
Vendys II Device
Your participation in this study will be over after your blood vessel health is measured 1 time with the Vendys II device
干预措施: Vendys II Device (Device)
结局指标
主要结局
The use of VENDYS-II in children and AYA as a measure of vascular endothelial function.
时间窗: through study completion, an average of 1 year
Feasibility of the Use of VENDYS-II in Children and AYA as a Measure of Vascular Endothelial Function
时间窗: 1 day
Completion of assessment by at least 70% of participants
次要结局
未报告次要终点