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

NCT05590039 | Completed Results FDA Device

• 1 other identifier: 7053-PL01-2022
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 2

Brief 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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Treatment for MyEllevate Procedure

EXPERIMENTAL

The subjects were treated with the MyEllevate procedure.

Device: MyEllevate Procedure

Interventions

MyEllevate Procedure DEVICE

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.

Treatment for MyEllevate Procedure

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cynosure, Inc.: lead

Study Sites (2)

New Jersey Plastic Surgery

Montclair, New Jersey, 07042, United States

Location

Aesthetic Pavilion Ambulatory Surgery Center

Staten Island, New York, 10306, United States

Location

Related Publications (1)

• 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.

  PMID: 31896400 RESULT

Results Point of Contact

• Title: Jamie Trimper
• Organization: Cynosure

jamie.trimper@cynosure.com

(201) 479-9612

Study Officials

• David Canavan

  Cynosure, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2022
• First Posted: October 21, 2022
• Study Start: July 8, 2022
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2023
• Last Updated: August 20, 2024
• Results First Posted: August 20, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)