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Vascular
+3

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

Sponsored by M.D. Anderson Cancer Center

About this trial

Last updated 7 months ago

Study ID

2020-1309

Status

Recruiting

Type

Interventional

Phase

N/A

Placebo

No

Accepting

18-75 Years
6 to 26 Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Started 4 years ago

What is this trial about?

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).

What are the Participation Requirements?

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.

Locations

Location

Status

Recruiting