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Feasibility of Digital Thermal Monitoring to Assess Endothelium-Dependent Vasodilation in Patients Undergoing Hematopoietic Cell Transplantation (HCT)

Not Applicable
Recruiting
Conditions
Vascular
Endothelial
Endothelix
Endothelial Dysfunction
Interventions
Device: Vendys II Device
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
RECRUITING
Sex
All
Target Recruitment
50
Inclusion Criteria

Not provided

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Exclusion Criteria
  • 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.

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Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
Vendys II DeviceVendys II DeviceYour participation in this study will be over after your blood vessel health is measured 1 time with the Vendys II device
Primary Outcome Measures
NameTimeMethod
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
NameTimeMethod

Trial Locations

Locations (1)

M D Anderson Cancer Center

🇺🇸

Houston, Texas, United States

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