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NCT05029752 Clinical Trial

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

Endothelial Dysfunction Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05029752
Other study ID # 2020-1309
Secondary ID NCI-2021-09419
Status Recruiting
Phase N/A
First received
Last updated
Start date June 30, 2021
Est. completion date June 30, 2024

Study information
Verified date October 2023
Source M.D. Anderson Cancer Center
Contact Dristhi Ragoonanan
Phone (713) 792-6620
Email dragoonanan@mdanderson.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).

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 information / eligibility
Status Recruiting
Enrollment 50
Est. completion date June 30, 2024
Est. primary completion date June 30, 2024
Accepts healthy volunteers No
Gender All
Age group 6 Years to 26 Years
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Vendys II Device
Using the device

Locations
Country Name City State
United States M D Anderson Cancer Center Houston Texas

Sponsors (1)
Lead Sponsor Collaborator
M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary The use of VENDYS-II in children and AYA as a measure of vascular endothelial function. through study completion, an average of 1 year
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