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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2021-09419 | Other Identifier | NCI-CTRP Clinical Trials Process Registry |
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<75% participation
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vendys II Device | Other | Your participation in this study will be over after your blood vessel health is measured 1 time with the Vendys II device |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vendys II Device | Device | Using the device |
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| Measure | Description | Time Frame |
|---|---|---|
| The use of VENDYS-II in children and AYA as a measure of vascular endothelial function. | through study completion, an average of 1 year |
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Keri Schadler | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| M D Anderson Cancer Center | Houston | Texas | 77030 | United States |
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| Label | URL |
|---|---|
| M D Anderson Cancer Center | View source |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Apr 11, 2024 | Sep 3, 2025 |
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| ICF_000.pdf |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 17, 2026 |