Evaluation of Physician Volumetric Accuracy During Filler Injections
|ClinicalTrials.gov Identifier: NCT03584347|
Recruitment Status : Completed
First Posted : July 12, 2018
Last Update Posted : January 10, 2019
- Evaluate the ability of aesthetic physicians to accurately inject a specific amount (i.e., 0.2cc) of HA soft tissue filler; and
- 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)|
|Actual Enrollment :||13 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Completion Date :||September 3, 2018|
- 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.
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03584347
|Victoria Park Medispa|
|Westmount, Quebec, Canada, H3Z1C3|