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

Status

Terminated

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05029752

Enrollment

Registered

2021-09-01

Start date

2021-06-30

Completion date

2025-08-29

Last updated

2026-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endothelial, Endothelial Dysfunction, Endothelix, Vascular

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).

Detailed 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.

Interventions

DEVICEVendys II Device

Using the device

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

6 Years to 26 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Feasibility of the Use of VENDYS-II in Children and AYA as a Measure of Vascular Endothelial Function	1 day	Completion of assessment by at least 70% of participants

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORKeri Schadler

M.D. Anderson Cancer Center

Baseline characteristics

Characteristic	—
Age, Categorical <=18 years	17 Participants
Age, Categorical >=65 years	0 Participants
Age, Categorical Between 18 and 65 years	10 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants
Race (NIH/OMB) Asian	0 Participants
Race (NIH/OMB) Black or African American	2 Participants
Race (NIH/OMB) More than one race	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants
Race (NIH/OMB) White	18 Participants
Region of Enrollment United States	4 participants
Sex: Female, Male Female	3 Participants
Sex: Female, Male Male	0 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk	EG003 affected / at risk
deaths Total, all-cause mortality	0 / 1	0 / 6	0 / 4	0 / 9
other Total, other adverse events	0 / 1	0 / 6	0 / 4	0 / 9
serious Total, serious adverse events	0 / 1	0 / 6	0 / 4	0 / 9

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 16, 2026