NCT05029752

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 6 Years – 26 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Vascular
• Endothelial
• Endothelial Dysfunction
• Endothelix

Interventions

Type	Name	Description
DEVICE	Vendys II Device	Using the device

Timeline

• Start date: 2021-06-30
• Primary completion: 2025-08-29
• Completion: 2025-08-29
• First posted: 2021-09-01
• Last updated: 2025-09-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study