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

October 26, 2023 updated by: M.D. Anderson Cancer Center
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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 26 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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
Device: Vendys II Device
Using the device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The use of VENDYS-II in children and AYA as a measure of vascular endothelial function.
Time Frame: through study completion, an average of 1 year
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Investigators

  • Principal Investigator: Dristhi Ragoonanan, M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 30, 2021

Primary Completion (Estimated)

June 30, 2024

Study Completion (Estimated)

June 30, 2024

Study Registration Dates

First Submitted

August 25, 2021

First Submitted That Met QC Criteria

August 30, 2021

First Posted (Actual)

September 1, 2021

Study Record Updates

Last Update Posted (Actual)

October 30, 2023

Last Update Submitted That Met QC Criteria

October 26, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 2020-1309
  • NCI-2021-09419 (Other Identifier: NCI-CTRP Clinical Trials Process Registry)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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