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
- 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)|
|Estimated Enrollment :||10 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|
|Estimated 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.
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
|Victoria Park Medispa|
|Westmount, Quebec, Canada, H3Z1C3|