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

Last updated: June 2, 2025
Sponsor: M.D. Anderson Cancer Center
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Atherosclerosis

Treatment

Vendys II Device

Clinical Study ID

NCT05029752
2020-1309
NCI-2021-09419
  • Ages 6-26
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria for HCT candidates:

  • Children, adolescents and young adults (AYA) 6-26 years of age who are HCTcandidates

  • Recipients within 30 days prior to or within 14 days after autologous and allogeneicHCT.

-. 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

Exclusion Criteria:

  • Any subject who does not consent/assent to participation.

-. Any subject with an injury or deformation to the index finger which preventsproper fit of the device.

  • Any subject with skin toxicity or neuropathy which prevents comfortable use of thedevice.

Study Design

Total Participants: 27
Treatment Group(s): 1
Primary Treatment: Vendys II Device
Phase:
Study Start date:
June 30, 2021
Estimated Completion Date:
June 30, 2026

Study 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.

Connect with a study center

  • M D Anderson Cancer Center

    Houston, Texas 77030
    United States

    Site Not Available

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