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
• Start date: June 30, 2021
• Est. completion date: June 30, 2026

Study information

• Verified date: May 2024
• Source: M.D. Anderson Cancer Center
• Contact: Dristhi Ragoonanan
• Phone: (713) 792-6620
• Email: dragoonanan[@]mdanderson.org
• Is FDA regulated: No
• 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, 2026
• Est. primary completion date: June 30, 2026
• 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.

Related Conditions & MeSH terms

• Endothelial Dysfunction
• Vascular

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

External Links

•   M D Anderson Cancer Center