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
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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TERMINATED
NA
27 participants
INTERVENTIONAL
2021-06-30
2025-08-29
Brief Summary
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Detailed Description
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-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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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
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
Vendys II Device
Using the device
Interventions
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Vendys II Device
Using the device
Eligibility Criteria
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Inclusion Criteria
* 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 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.
6 Years
26 Years
ALL
No
Sponsors
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M.D. Anderson Cancer Center
OTHER
Responsible Party
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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
Countries
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Provided Documents
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Document Type: Informed Consent Form
Related Links
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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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