VascularNCT05029752
Feasibility of Digital Thermal Monitoring to Assess Endothelium-Dependent Vasodilation in Patients Undergoing Hematopoietic Cell Transplantation (HCT)
A study testing Vendys II Device in people with Vascular and Endothelial, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
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)… Read more about this study
- Who is it for?
- Ages 6 to 26 years
- Conditions the study is for
- Vascular, Endothelial, Endothelial Dysfunction
- What is being tested?
- Vendys II Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jun 2021to 29 Aug 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 26 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
- Healthy HCT donors between the ages of 6-26 years of age.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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).
Read the detailed description
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.
- Conditions
- Vascular, Endothelial, Endothelial Dysfunction, Endothelix
- Being tested
- Vendys II Device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vendys II DeviceDevice
Using the device
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: Vendys II Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of the Use of VENDYS-II in Children and AYA as a Measure of Vascular Endothelial Function
Completion of assessment by at least 70% of participants
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2021
- Study start30 Jun 2021
- Primary completion29 Aug 2025
- Study completion29 Aug 2025
Why it stopped: \<75% participation
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for VascularStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Keri Schadler, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05029752
- Sponsor's protocol ID
- 2020-1309
- Other IDs
- NCI-2021-09419
- Status last verified
- Jun 2026
- First submitted
- 25 Aug 2021
- Last updated
- 15 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Digital Thermal Monitoring to Assess Endothelium-Dependent Vasodilation in Patients Undergoing Hematopoietic Cell Transplantation (HCT)
- ClinicalTrials.gov ID
- NCT05029752
- Acronym / sponsor ID
- 2020-1309
- Conditions
- Vascular, Endothelial, Endothelial Dysfunction, Endothelix
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: \<75% participation
- Enrolment
- 27 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 30 Jun 2021 (actual)
- Primary completion
- 29 Aug 2025 (actual)
- Study completion
- 29 Aug 2025 (actual)
- First posted
- 1 Sep 2021 (actual)
- Results
- Posted 15 Jul 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vendys II Device | Other | Device: Vendys II DeviceYour participation in this study will be over after your blood vessel health is measured 1 time with the Vendys II device |
Who may qualify
- Ages
- 6 to 26 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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
- Healthy HCT donors between the ages of 6-26 years of age.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vendys II DeviceUsing the device | Device | Vendys II Device |
Primary outcome
Feasibility of the Use of VENDYS-II in Children and AYA as a Measure of Vascular Endothelial Function
Time frame: 1 day
Completion of assessment by at least 70% of participants
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- M D Anderson Cancer CenterLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Keri Schadler principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vendys II Device in people with Vascular and Endothelial, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 15 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of the Use of VENDYS-II in Children and AYA as a Measure of Vascular Endothelial Function (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2026.