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

M.D. Anderson Cancer Center

Status: Terminated

Conditions: Endothelial Dysfunction; Endothelial; Vascular; Endothelix

Treatments: Device: Vendys II Device

Study type: Interventional

Funder types: Other

Identifiers

NCT05029752

NCI-2021-09419 (Other Identifier)

2020-1309

Details and patient eligibility

About

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).

Full 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.

Enrollment: 27 patients

Sex: All

Ages: 6 to 26 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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27 participants in 1 patient group

Vendys II Device

Other group

Description:

Your participation in this study will be over after your blood vessel health is measured 1 time with the Vendys II device

Treatment:

Device: Vendys II Device