Evaluation of Physician Volumetric Accuracy During Filler Injections

Injection Site Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03584347
• Other study ID #: 2018-06-001
• Status: Completed
• Phase: N/A
• Start date: June 3, 2018
• Est. completion date: September 3, 2018

Study information

• Verified date: January 2019
• Source: Erevna Innovations Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: September 3, 2018
• Est. primary completion date: June 10, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 80 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

Related Conditions & MeSH terms

• Injection Site

Intervention

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.

Locations

Country	Name	City	State
Canada	Victoria Park Medispa	Westmount	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Erevna Innovations Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Volumetric accuracy of HA filler injections using observational methods	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.	Baseline
Primary	Volumetric accuracy of HA filler expulsions over a scale	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.	Baseline