Feasibility of Digital Thermal Monitoring to Assess Endothelium-Dependent Vasodilation in Patients Undergoing Hematopoietic Cell Transplantation (HCT)
- Conditions
- VascularEndothelialEndothelixEndothelial Dysfunction
- Registration Number
- NCT05029752
- Lead Sponsor
- M.D. Anderson Cancer Center
- Brief Summary
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).
- Detailed Description
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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 27
Not provided
-
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method The use of VENDYS-II in children and AYA as a measure of vascular endothelial function. through study completion, an average of 1 year
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
M D Anderson Cancer Center
🇺🇸Houston, Texas, United States
M D Anderson Cancer Center🇺🇸Houston, Texas, United States