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

NCT ID: NCT05590039

Last Updated: 2024-08-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-08
• Study Completion Date: 2023-06-30

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.

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.

Conditions

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

Study Design

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

Study Groups

Treatment for MyEllevate Procedure

The subjects were treated with the MyEllevate procedure.

Group Type: EXPERIMENTAL

MyEllevate Procedure

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cynosure, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Canavan

Role: STUDY_DIRECTOR

Cynosure, Inc.

Locations

New Jersey Plastic Surgery

Montclair, New Jersey, United States

Aesthetic Pavilion Ambulatory Surgery Center

Staten Island, New York, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 31896400 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

7053-PL01-2022

Identifier Type: -

Identifier Source: org_study_id