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OpenTrials
Completed

NCT Number: NCT03584347

Evaluation of Physician Volumetric Accuracy During Filler Injections

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.

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Key information

Conditions

Injection Site

Age range

21 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Victoria Park Medispa

Westmount, Quebec, H3Z1C3, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • N/A

Treatment and study plan

Injection of filler material

Behavioral

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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Erevna Innovations Inc.

Other

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jul 12, 2018
Registry last updated
Jan 10, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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