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

NCT ID: NCT05029752

Last Updated: 2025-09-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-30

Study Completion Date

2025-08-29

Brief Summary

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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

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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.

Conditions

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Vascular Endothelial Endothelial Dysfunction Endothelix

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Vendys II Device

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

Group Type OTHER

Vendys II Device

Intervention Type DEVICE

Using the device

Interventions

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Vendys II Device

Using the device

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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.

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.
Minimum Eligible Age

6 Years

Maximum Eligible Age

26 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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M.D. Anderson Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Keri Schadler

Role: PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Locations

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M D Anderson Cancer Center

Houston, Texas, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Informed Consent Form

View Document

Related Links

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http://www.mdanderson.org

M D Anderson Cancer Center

Other Identifiers

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NCI-2021-09419

Identifier Type: OTHER

Identifier Source: secondary_id

2020-1309

Identifier Type: -

Identifier Source: org_study_id

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