Blood FlowNCT04232111
Effect of AVACEN 100 on Brachial Artery Blood Flow
A study testing Heat and Vacuum in people with Blood Flow, run by San Diego State University.
Trial summary
Determine effect of AVACEN 100 on brachial artery blood flow Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Blood Flow
- What is being tested?
- Heat and Vacuum
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2020to 1 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- anyone within specified age
Who cannot join
- anyone outside specified age
About this study
Determine effect of AVACEN 100 on brachial artery blood flow
Read the detailed description
Blood flow measured via ultrasound doppler
- Conditions
- Blood Flow
- Being tested
- Heat, Vacuum, sham
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HeatDevice
Heat applied to hand
VacuumDevice
vacuum applied to hand
shamDevice
neither heat nor vacuum
| Study group | Role | What they receive |
|---|---|---|
| Thermoneutral | Sham comparator | Neither heat nor vacuum applied to hand Receives: Device: sham |
| Heat and Vacuum | Experimental | Heat and vacuum applied to hand Receives: Device: Heat; Device: Vacuum |
| Heat only | Experimental | Only heat applied to hand Receives: Device: Heat |
What is being measured
The primary outcome is the main question the study is designed to answer.
brachial artery blood flow via ultrasound doppler
Measured: 10 min
brachial artery blood flow via ultrasound doppler
Measured: 20 min
brachial artery blood flow via ultrasound doppler
Measured: 30 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2020
- Study start1 Feb 2020 (estimated)
- Primary completion1 Jun 2020 (estimated)
- Study completion1 Jun 2020 (estimated)
Why it stopped: The study never took off and the sponsor lost interest.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood FlowStudies of the same condition, open and under way.
- More trials run by San Diego State UniversityThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- San Diego State University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04232111
- Sponsor's protocol ID
- AVACENBF
- Status last verified
- May 2025
- First submitted
- 11 Jan 2020
- Last updated
- 21 May 2025
- Results posted
- 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 21 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of AVACEN 100 on Brachial Artery Blood Flow
- ClinicalTrials.gov ID
- NCT04232111
- Acronym / sponsor ID
- AVACENBF
- Conditions
- Blood Flow
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study never took off and the sponsor lost interest.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- San Diego State UniversityUniversity, hospital or other
- Study start
- 1 Feb 2020 (estimated)
- Primary completion
- 1 Jun 2020 (estimated)
- Study completion
- 1 Jun 2020 (estimated)
- First posted
- 18 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Determine effect of AVACEN 100 on brachial artery blood flow
Detailed description
Blood flow measured via ultrasound doppler
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Thermoneutral | Sham comparator | Device: shamNeither heat nor vacuum applied to hand |
| Heat and Vacuum | Experimental | Device: Heat, Device: VacuumHeat and vacuum applied to hand |
| Heat only | Experimental | Device: HeatOnly heat applied to hand |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- anyone within specified age
Key exclusion criteria (1 listed)
- anyone outside specified age
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 |
|---|---|---|
| HeatHeat applied to hand | Device | Heat and Vacuum, Heat only |
| Vacuumvacuum applied to hand | Device | Heat and Vacuum |
| shamneither heat nor vacuum | Device | Thermoneutral |
Primary outcome
brachial artery blood flow via ultrasound doppler
Time frame: 10 min
brachial artery blood flow via ultrasound doppler
Time frame: 20 min
brachial artery blood flow via ultrasound doppler
Time frame: 30 min
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Heat and Vacuum in people with Blood Flow, run by San Diego State University.
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 1 inclusion and 1 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: withdrawn, as of the sponsor's last update on 21 May 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
brachial artery blood flow via ultrasound doppler (time frame: 10 min). The study lists 3 primary outcomes in all. 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 21 May 2025.