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Impact of Near-Infrared Vein Mapping on Outcomes and Satisfaction After Botox/Filler Treatment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04240080
Recruitment Status : Recruiting
First Posted : January 27, 2020
Last Update Posted : January 27, 2020
Sponsor:
Information provided by (Responsible Party):
William J. Casey, III, Mayo Clinic

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

Condition or disease Intervention/treatment Phase
Wrinkle Device: Accuvein® Veinfinder Not Applicable

Detailed Description:

Facial Botox/filler injections carry risk of puncturing superficial veins, leading to bruising and pain. Our study will investigate the utility of non-invasive vein imaging (specifically near-infrared light reflection) on the incidence of pain/bruising/hematoma and patient satisfaction after facial injections.

The current standard of care for facial injection procedures does not involve any modality of facial venous mapping. Vein mapping is a non-invasive, simple task that takes very little time to conduct. One risk is patient time, however maximum extra time needed will be 5 minutes during the clinical visit. This potential extra time in mind, the benefits far outweigh the risks.

Two cohorts of patients will be prospectively compared following randomization, those who did have pre-procedure venous mapping prior to injection versus those who did not. Data will be analyzed with regard to bruising and swelling following injection, as well as other potential complications such as hematoma or infection, along with patient satisfaction survey information.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: The Impact of Near-Infrared Vein Mapping on Outcomes and Satisfaction After Botox/Filler Treatment
Actual Study Start Date : January 10, 2020
Estimated Primary Completion Date : January 1, 2021
Estimated Study Completion Date : January 1, 2021

Arm Intervention/treatment
No Intervention: Control Goup
Subjects will undergo clinically indicated facial injection procedures per standard of care without venous mapping
Experimental: Intervention Group
Subjects will undergo clinically indicated facial injection procedure with pre-procedural facial venous mapping by Accuvein® Veinfinder
Device: Accuvein® Veinfinder
Near-infrared light reflection utilized by healthcare providers to see superficial veins under the skin.




Primary Outcome Measures :
  1. Patient satisfaction [ Time Frame: Approximately 7-10 days following the procedure ]
    Measured using the self-reported FACE-Q satisfaction score, using a scale of 1=definitely disagree and 4=definitely agree


Secondary Outcome Measures :
  1. Rate of Bruising/Hematoma [ Time Frame: Approximately 7-10 days following the procedure ]
    Number of subjects to experience bruising/hematoma post facial injection procedure



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Patients undergoing aesthetic facial procedures not requiring needle injection

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04240080


Contacts
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Contact: William Casey, MD 480-342-2976 Casey.williamjoseph@mayo.edu
Contact: Jacob Hammond, MD 480-342-2000 Hammond.jacob@mayo.edu

Locations
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United States, Arizona
Mayo Clinic Recruiting
Scottsdale, Arizona, United States, 85259
Contact: William Casey, MD    480-342-2976    Casey.williamjoseph@mayo.edu   
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: William Casey III, MD Mayo Clinic
Additional Information:
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Responsible Party: William J. Casey, III, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT04240080    
Other Study ID Numbers: 19-011561
First Posted: January 27, 2020    Key Record Dates
Last Update Posted: January 27, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No