Using a device to monitor blood vessel health in young patients undergoing stem cell transplants
Feasibility of Digital Thermal Monitoring to Assess Endothelium-Dependent Vasodilation in Patients Undergoing Hematopoietic Cell Transplantation (HCT)
This study tests if a special device can safely check the blood vessel health of children and young adults getting stem cell transplants to see how well it works.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 6 Years to 26 Years |
| Sex | All |
| Sponsor | M.D. Anderson Cancer Center Academic / other |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT05029752 on ClinicalTrials.gov |
What this trial studies
This study evaluates the feasibility of the Vendys II device, which uses digital thermal monitoring to assess vascular health, specifically in children and young adults undergoing hematopoietic cell transplantation (HCT). The primary objective is to determine if at least 70% of participants can complete the evaluation of their vascular endothelial function. Additionally, the study will track any adverse events that may prevent participants from completing the assessment. The goal is to provide insights into the vascular reactivity of this patient population.
Who should consider this trial
Good fit: Ideal candidates include children and young adults aged 6-26 who are candidates for hematopoietic cell transplantation.
Not a fit: Patients who have injuries or deformities to their index fingers or those with skin toxicity or neuropathy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved monitoring of vascular health in young patients undergoing HCT, potentially enhancing their overall care.
How similar studies have performed: While the use of digital thermal monitoring for vascular assessment is established, this specific application in HCT patients is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Houston, Texas
- M D Anderson Cancer Center — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Dristhi Ragoonanan — M.D. Anderson Cancer Center
- Study coordinator: Dristhi Ragoonanan
- Email: dragoonanan@mdanderson.org
- Phone: (713) 792-6620
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.