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

NCT05029752 | Terminated FDA Device

• 2 other identifiers: 2020-1309NCI-2021-09419
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Vascular; Endothelial; Endothelial Dysfunction; Endothelix

Outcome Measures

Primary Outcomes (1)

• The use of VENDYS-II in children and AYA as a measure of vascular endothelial function.

  through study completion, an average of 1 year

Study Arms (1)

Vendys II Device

OTHER

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

Device: Vendys II Device

Interventions

Vendys II Device DEVICE

Using the device

Vendys II Device

Eligibility Criteria

• Age: 6 Years - 26 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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
• \- Healthy HCT donors between the ages of 6-26 years of age.

You may not qualify if:

• 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.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• M D Anderson Cancer Center

Study Officials

• Keri Schadler

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2021
• First Posted: September 1, 2021
• Study Start: June 30, 2021
• Primary Completion: August 29, 2025
• Study Completion: August 29, 2025
• Last Updated: September 10, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)