Feasibility of Digital Thermal Monitoring to Assess Endothelium-Dependent Vasodilation in Patients Undergoing Hematopoietic Cell Transplantation (HCT)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- M.D. Anderson Cancer Center
- Enrollment
- 27
- Locations
- 2
- Primary Endpoint
- The use of VENDYS-II in children and AYA as a measure of vascular endothelial function.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 6 Years to 26 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
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.
Arms & Interventions
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
Intervention: Vendys II Device (Device)
Outcomes
Primary Outcomes
The use of VENDYS-II in children and AYA as a measure of vascular endothelial function.
Time Frame: 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
Time Frame: 1 day
Completion of assessment by at least 70% of participants
Secondary Outcomes
No secondary outcomes reported