MedPath

Evaluation of Physician Volumetric Accuracy During Filler Injections

Not Applicable
Completed
Conditions
Injection Site
Registration Number
NCT03584347
Lead Sponsor
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
13
Inclusion Criteria
  • Board-certified plastic surgeon, dermatologist, or oculoplastic surgeon.
Exclusion Criteria
  • N/A

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Primary Outcome Measures
NameTimeMethod
Volumetric accuracy of HA filler injections using observational methodsBaseline

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.

Volumetric accuracy of HA filler expulsions over a scaleBaseline

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.

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Victoria Park Medispa

🇨🇦

Westmount, Quebec, Canada

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