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

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

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.

Study Overview

• Status: Completed
• Conditions: Soft Tissue Approximation; Elevation of Subdermis; Elevation of Underlying Muscle
• Intervention / Treatment: Device: MyEllevate Procedure

Detailed Description

Subjects are to be enrolled in this clinical study if they are a healthy male or female between the age of 18 - 65. Up to 10 subjects will be enrolled at 2 study centers. All subjects will attend a screening/pre-procedure visit which may be performed on the same day as the procedure visit but no more than 30 days prior to their procedure.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Montclair, New Jersey, United States, 07042
      • New Jersey Plastic Surgery
  • New York
    • Staten Island, New York, United States, 10306
      • Aesthetic Pavilion Ambulatory Surgery Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• A healthy male or female between the age of 18 - 65.
• Must have any or all the following: visible platysma bands, glands and/or sagging in the submentum, jawline and/or neck.
• Reads and understands English.
• Understands and accepts obligation not to receive any other procedures on the treatment area through the length of the study.
• Understands and accepts the obligation and is logistically able to be present for all visits.
• Is willing to comply with all requirements of the study and sign the informed consent document.

Exclusion Criteria:

Is pregnant or of childbearing potential and not using medically effective birth control, or has been pregnant in the last 3 months, currently breast feeding or planning a pregnancy during the study.

• Is currently enrolled in an investigational drug or device trial, or has received an investigational drug or been treated with an investigational device within in the area to be treated 6 months (or at the discretion of the Investigator) prior to entering this study.
• Have received any treatments or procedures (including injectables such as Botox or fillers) in the area to be treated at least 4 months prior to treatment.
• Take antiplatelets, anticoagulants, thrombolytics, or anti-inflammatories.
• Have an active localized or systemic infection.
• Have an open wound in area being treated.
• Have a significant systemic illness or an illness localized in area being treated.
• Have had recent surgeries or problems in the treatment area (e.g. neck fracture, neck sprain, pinched nerve, spondylosis, arthritis in the neck).
• Have a history of thrombophlebitis.
• Have a history of heart failure or kidney disease.
• Have a history of allergic reaction or intolerance to the anesthesia used during the procedure.
• Have a history of poor wound healing.
• Have a history of poor circulation.
• Have a systemic autoimmune disease known to impair wound healing.
• Have a history of keloid formation.
• Currently enrolled in an investigational drug or device trial, or has received an investigational drug or been treated with an investigational device within the area to be treated 6 months (or at the discretion of the Investigator) prior to entering this study.
• Has any condition or is in a situation which in the investigators opinion may put the subject at significant risk, may confound study results or may interfere significantly with the subject's participation.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Treatment for MyEllevate Procedure; The subjects were treated with the MyEllevate procedure.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physician Global Aesthetic Improvement Score (PGAIS)	The physician will grade the improvement that they see at the 30 day follow up (30 days post treatment). They will grade them as one of the following: Very Much Improved, Much Improved, Improved, No Change, or Worsened.	30 days post last treatment

Collaborators and Investigators

• Sponsor: Cynosure, Inc.
• Investigators: Study Director: David Canavan, Cynosure, Inc.

Publications and helpful links

General Publications

• Gupta V, Sharma VK. Skin typing: Fitzpatrick grading and others. Clin Dermatol. 2019 Sep-Oct;37(5):430-436. doi: 10.1016/j.clindermatol.2019.07.010. Epub 2019 Jul 17.

Study record dates

Study Major Dates

• Study Start (Actual): July 8, 2022
• Primary Completion (Actual): June 30, 2023
• Study Completion (Actual): June 30, 2023

Study Registration Dates

• First Submitted: October 18, 2022
• First Submitted That Met QC Criteria: October 18, 2022
• First Posted (Actual): October 21, 2022

Study Record Updates

• Last Update Posted (Actual): August 20, 2024
• Last Update Submitted That Met QC Criteria: July 25, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 7053-PL01-2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes