NCT04240080

Brief Summary

Researchers are studying how vein mapping impacts patient outcomes and satisfaction after facial injection procedures.

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 Jan 2020

Longer than P75 for not_applicable

Status
withdrawn

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 10, 2020

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

January 22, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 27, 2020

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

May 1, 2024

Status Verified

April 1, 2024

Enrollment Period

4.9 years

First QC Date

January 22, 2020

Last Update Submit

April 30, 2024

Conditions

Wrinkle

Outcome Measures

Primary Outcomes (1)

  • Patient satisfaction

    Measured using the self-reported FACE-Q satisfaction score, using a scale of 1=definitely disagree and 4=definitely agree

    Approximately 7-10 days following the procedure

Secondary Outcomes (1)

  • Rate of Bruising/Hematoma

    Approximately 7-10 days following the procedure

Study Arms (2)

Control Goup

NO INTERVENTION

Subjects will undergo clinically indicated facial injection procedures per standard of care without venous mapping

Intervention Group

EXPERIMENTAL

Subjects will undergo clinically indicated facial injection procedure with pre-procedural facial venous mapping by Accuvein® Veinfinder

Device: Accuvein® Veinfinder

Interventions

Accuvein® VeinfinderDEVICE

Near-infrared light reflection utilized by healthcare providers to see superficial veins under the skin.

Intervention Group

Eligibility Criteria

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

You may qualify if:

  • Patients pursuing aesthetic/therapeutic facial injection procedures (botox/filler)

You may not qualify if:

  • Patients undergoing aesthetic facial procedures not requiring needle injection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

Study Officials

  • William Casey III, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 22, 2020

First Posted

January 27, 2020

Study Start

January 10, 2020

Primary Completion

December 1, 2024

Study Completion

December 1, 2024

Last Updated

May 1, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share