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Evaluation of Physician Volumetric Accuracy During Filler Injections

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ClinicalTrials.gov Identifier: NCT03584347
Recruitment Status : Enrolling by invitation
First Posted : July 12, 2018
Last Update Posted : July 12, 2018
Sponsor:
Information provided by (Responsible Party):
Erevna Innovations Inc.

Brief Summary:

Objectives

  1. Evaluate the ability of aesthetic physicians to accurately inject a specific amount (i.e., 0.2cc) of HA soft tissue filler; and
  2. Investigate the effect of different HA gel properties (e.g., G', cohesivity, viscoelasticity) on an injector's performance accuracy.

Condition or disease Intervention/treatment Phase
Injection Site Behavioral: Injection of filler material Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Evaluation of Physician Volumetric Accuracy During Hyaluronic Acid Soft Tissue Filler Injections and the Effect of Products' Biophysical Properties on an Injector's Performance: An Observational, Proof-of-concept Study
Actual Study Start Date : June 3, 2018
Actual Primary Completion Date : June 10, 2018
Estimated Study Completion Date : September 3, 2018

Intervention Details:
  • Behavioral: Injection of filler material
    Subjects will be blind folded and asked to deposit 0.2cc's of each of the four investigational products, in a randomized order. First, over a weight and then into a porcine membrane.


Primary Outcome Measures :
  1. Volumetric accuracy of HA filler injections using observational methods [ Time Frame: Baseline ]
    physicians will attempt to inject 0.2CC of four HA products into a porcine membrane. Volumes will be measured in CC's and their accuracy assessed based on the amount of product left in the syringe.

  2. Volumetric accuracy of HA filler expulsions over a scale [ Time Frame: Baseline ]
    Physicians will attempt to dispense 0.2CC of four different HA products. They will do this into free air, over a scale. The weights will be calculated in grams and converted to CC's. The scale is the "Smart Weight" digital milligram scale, JDS20 edition. It's specifications are as follows: capacity: 20g/100ct/308.8gn/12.86dwt; readability: 0.001g/0.005ct/0.02gn/0.001dwt; scale dimensions: 3x5x0.8"; accuracy of 0.001grams and capacity of 20grams.



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Ages Eligible for Study:   21 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Board-certified plastic surgeon, dermatologist, or oculoplastic surgeon.

Exclusion Criteria:


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): NCT03584347


Locations
Canada, Quebec
Victoria Park Medispa
Westmount, Quebec, Canada, H3Z1C3
Sponsors and Collaborators
Erevna Innovations Inc.

Responsible Party: Erevna Innovations Inc.
ClinicalTrials.gov Identifier: NCT03584347     History of Changes
Other Study ID Numbers: 2018-06-001
First Posted: July 12, 2018    Key Record Dates
Last Update Posted: July 12, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No