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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03584347
Other study ID # 2018-06-001
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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:

Study Design


Related Conditions & MeSH terms


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
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