NCT04232111

Brief Summary

Determine effect of AVACEN 100 on brachial artery blood flow

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Feb 2020

Shorter than P25 for not_applicable

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 11, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 18, 2020

Completed
14 days until next milestone

Study Start

First participant enrolled

February 1, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2020

Completed
Last Updated

May 21, 2025

Status Verified

May 1, 2025

Enrollment Period

4 months

First QC Date

January 11, 2020

Last Update Submit

May 15, 2025

Conditions

Blood Flow

Outcome Measures

Primary Outcomes (3)

  • brachial artery blood flow via ultrasound doppler

    10 min

  • brachial artery blood flow via ultrasound doppler

    20 min

  • brachial artery blood flow via ultrasound doppler

    30 min

Study Arms (3)

Thermoneutral

SHAM COMPARATOR

Neither heat nor vacuum applied to hand

Device: sham

Heat and Vacuum

EXPERIMENTAL

Heat and vacuum applied to hand

Device: HeatDevice: Vacuum

Heat only

EXPERIMENTAL

Only heat applied to hand

Device: Heat

Interventions

HeatDEVICE

Heat applied to hand

Heat and VacuumHeat only
VacuumDEVICE

vacuum applied to hand

Heat and Vacuum
shamDEVICE

neither heat nor vacuum

Thermoneutral

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • anyone within specified age

You may not qualify if:

  • anyone outside specified age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Double-blind
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 11, 2020

First Posted

January 18, 2020

Study Start

February 1, 2020

Primary Completion

June 1, 2020

Study Completion

June 1, 2020

Last Updated

May 21, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share