Evaluation of Physician Volumetric Accuracy During Filler Injections

NCT ID: NCT03584347

Last Updated: 2019-01-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-06-03
• Study Completion Date: 2018-09-03

Brief 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.

Conditions

Injection Site

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• N/A

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Erevna Innovations Inc.

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Victoria Park Medispa

Westmount, Quebec, Canada

Countries

Canada

Other Identifiers

2018-06-001

Identifier Type: -

Identifier Source: org_study_id