Clinical trial NCT05590039: Study To Evaluate The Safety And Efficacy Of The MyEllevate® Procedure
Official title: Prospective Clinical Study To Evaluate The Safety And Efficacy Of The MyEllevate® Procedure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Soft Tissue Approximation
Elevation of Subdermis
Elevation of Underlying Muscle
Lead sponsor: Cynosure, Inc.
Sponsor class: INDUSTRY
First posted: 2022-10-21
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Physician Global Aesthetic Improvement Score (PGAIS)
timeFrame: 30 days post last treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Montclair
country: United States
facility: New Jersey Plastic Surgery
state: New Jersey
city: Staten Island
country: United States
facility: Aesthetic Pavilion Ambulatory Surgery Center
state: New York
Study officials:
affiliation: Cynosure, Inc.
name: David Canavan
role: STUDY_DIRECTOR
References:
citation: 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.