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Digital Thermal Monitoring for Endothelial Dysfunction

N/A

Recruiting

Led By Dristhi Ragoonanan

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

- Healthy HCT donors between the ages of 6-26 years of age.

Recipients within 30 days prior to or within 14 days after autologous and allogeneic HCT.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 1 year

Awards & highlights

Study Summary

This trial will study whether the Vendys II, a device that uses finger DTM to measure VRI, is feasible to use in children and AYAs undergoing HCT.

Who is the study for?

This trial is for children and young adults aged 6-26 who are about to undergo or have recently had a hematopoietic cell transplant (HCT). It includes both recipients within a month before/after HCT and healthy donors. Participants must fit the device on their index finger without pain or difficulty, consent to join, and not have skin toxicity or neuropathy affecting device use.Check my eligibility

What is being tested?

The study is testing the Vendys II device's ability to measure vascular health in patients undergoing HCT. The FDA-approved tool assesses how well blood vessels can dilate by monitoring temperature changes in the finger after temporarily stopping blood flow.See study design

What are the potential side effects?

Since this trial involves non-invasive digital thermal monitoring with the Vendys II device, there are minimal expected side effects. However, discomfort at the site of application due to pressure from the device could occur.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am a healthy donor aged 6-26 for hematopoietic cell transplantation.

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I have had a stem cell transplant within the last month or plan to have one in the next two weeks.

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I am between 6 and 26 years old and a candidate for a stem cell transplant.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, an average of 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

The use of VENDYS-II in children and AYA as a measure of vascular endothelial function.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Vendys II DeviceExperimental Treatment1 Intervention

Your participation in this study will be over after your blood vessel health is measured 1 time with the Vendys II device

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor

2,973 Previous Clinical Trials

1,789,271 Total Patients Enrolled

1 Trials studying Endothelial Dysfunction

90 Patients Enrolled for Endothelial Dysfunction

Dristhi RagoonananPrincipal InvestigatorM.D. Anderson Cancer Center

1 Previous Clinical Trials

500 Total Patients Enrolled

Kris MahadeoPrincipal InvestigatorM.D. Anderson Cancer Center

1 Previous Clinical Trials

500 Total Patients Enrolled

Media Library

Vendys II Device Clinical Trial Eligibility Overview. Trial Name: NCT05029752 — N/A

Endothelial Dysfunction Research Study Groups: Vendys II Device

Endothelial Dysfunction Clinical Trial 2023: Vendys II Device Highlights & Side Effects. Trial Name: NCT05029752 — N/A

Vendys II Device 2023 Treatment Timeline for Medical Study. Trial Name: NCT05029752 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are currently part of this research project?

"Affirmative. Clinicaltrials.gov lists this clinical trial as currently recruiting, with the first post having been made on June 30th 2021 and the last edited date being June 28th 2022. This study requires 50 individuals to be enrolled at a single site."

Answered by AI

Does my profile meet the criteria to join this research project?

"Candidates must meet the age bracket of 6 to 26 years old and have a diagnosis of endothelial dysfunction in order to be eligible for this study. As of now, approximately 50 patients are being enrolled."

Answered by AI

Does the age of eighty qualify one to participate in this research?

"As outlined in the study requirements, minors aged 6 and over up to young adults of 26 are able to participate."

Answered by AI

Are enrollment opportunities still available for this research trial?

"Affirmative, records hosted on clinicaltrials.gov indicate that this study is actively accepting participants. The trial was initially posted on June 30th 2021 and the latest update occurred on June 28th 2022. 50 patients need to be recruited from a single location for the experiment to move forward."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2021. "Feasibility of Digital Thermal Monitoring to Assess Endothelium-Dependent Vasodilation in Patients Undergoing Hematopoietic Cell Transplantation (HCT)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05029752.