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

• Sponsor: M.D. Anderson Cancer Center (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05029752
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 19.1
• Patients Per Site Per Month: 2.6

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Vascular; Endothelial; Endothelial Dysfunction; Endothelix	Device: Vendys II Device	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 50 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Feasibility of Digital Thermal Monitoring to Assess Endothelium-Dependent Vasodilation in Patients Undergoing Hematopoietic Cell Transplantation (HCT)
• Actual Study Start Date: Jun 30, 2021
• Anticipated Primary Completion Date: Jan 31, 2023
• Anticipated Study Completion Date: Jan 31, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

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]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 6 Years to 26 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	M D Anderson Cancer Center	Houston	Texas	United States	77030

Sponsors and Collaborators

• M.D. Anderson Cancer Center

Investigators

• Principal Investigator: Kris Mahadeo, M.D. Anderson Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• M D Anderson Cancer Center

Publications

None provided.

• Responsible Party: M.D. Anderson Cancer Center
• ClinicalTrials.gov Identifier: NCT05029752
• Other Study ID Numbers: 2020-1309; NCI-2021-09419
• First Posted: Sep 1, 2021
• Last Update Posted: Jun 30, 2022
• Last Verified: Jun 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes

Study Results

No Results Posted as of Jun 30, 2022