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Study To Evaluate The Safety And Efficacy Of The MyEllevate® Procedure

NCT05590039 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2024-08-20

Study results available
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Summary

The intended purpose of the MyEllevate® procedure used in this study is to assess the safety and efficacy of the procedure for soft tissue approximation and elevation of sub dermis and underlying muscle of the submentum \& jawline.

Conditions

  • Soft Tissue Approximation
  • Elevation of Subdermis
  • Elevation of Underlying Muscle

Interventions

DEVICE

MyEllevate Procedure

The defined study area will be identified and may be marked with a surgical marker. A local tumescent anesthetic, such as lidocaine, will be injected to the area prior to the procedure. The MyEllevate® device will be used in accordance with the Instructions for Use (IFU) manual for soft tissue approximation and elevation of sub dermis and underlying muscle of the submentum and jawline.

Sponsors & Collaborators

  • Cynosure, Inc.

    lead INDUSTRY

Principal Investigators

  • David Canavan · Cynosure, Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-08
Primary Completion
2023-06-30
Completion
2023-06-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05590039 on ClinicalTrials.gov