NCT03584347

Brief Summary

Objectives

  1. 1.Evaluate the ability of aesthetic physicians to accurately inject a specific amount (i.e., 0.2cc) of HA soft tissue filler; and
  2. 2.Investigate the effect of different HA gel properties (e.g., G', cohesivity, viscoelasticity) on an injector's performance accuracy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 3, 2018

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

June 7, 2018

Completed
3 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 10, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 12, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 3, 2018

Completed
Last Updated

January 10, 2019

Status Verified

January 1, 2019

Enrollment Period

7 days

First QC Date

June 7, 2018

Last Update Submit

January 8, 2019

Conditions

Injection Site

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Interventions

Injection of filler materialBEHAVIORAL

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.

Eligibility Criteria

Age21 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • N/A

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Victoria Park Medispa

Westmount, Quebec, H3Z1C3, Canada

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 7, 2018

First Posted

July 12, 2018

Study Start

June 3, 2018

Primary Completion

June 10, 2018

Study Completion

September 3, 2018

Last Updated

January 10, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)