Lutronic Genius System for Neck Treatment

Study Overview
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Brief Summary
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The Genius system is substantially equivalent to the Infini device (K121481). The study is a prospective, multi-site, non-randomized study of up to 30 treated subjects presenting for treatment of mild to moderate lines, wrinkles, textural concerns, and/or skin laxity of the neck.

Detailed Description
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At enrollment, standardized baseline/pretreatment 2D and 3D images will be obtained from each subject. Study subjects will receive three neck treatments completed 30 days apart. Subjects will be contacted via a phone call 3 days following each treatment to assess for adverse events and expected treatment effects. Effectiveness assessments will occur prior to Treatments #2 and #3, and a follow-up visit will be completed at 90 days following Treatment #3. Each assessment visit will include efficacy, adverse events, and expected treatment effects assessments, and post-treatment 2D and 3D digital images will be captured.

Official Title
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Exploratory Evaluation of the Lutronic Genius System for Treatment of the Neck

Conditions
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Wrinkle, Skin Laxity, Skin Texture Disorder

Intervention / Treatment
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* Device: Lutronic Genius System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female, age 18 years and older. Subject in good health. Fitzpatrick Skin Type I to VI. Mild to moderate lines, wrinkles, textural concerns, and/or skin laxity of the neck. Understands and accepts the obligation not to undergo any other procedures in the areas to be treated through the follow-up period. Willingness and ability to comply with protocol requirements, including returning for follow-up visits and abstaining from exclusionary procedures for the duration of the study. Post-menopausal, surgically sterilized, or using a medically acceptable form of birth control at least 3 months prior to enrollment and during the entire course of the study. Absence of physical or psychological conditions unacceptable to the investigator. Willingness and ability to provide written consent for study-required photography and adherence to photography procedures (i.e., removal of jewelry and makeup). Willingness and ability to provide written informed consent and HIPAA authorization prior to performance of any study-related procedure. Exclusion Criteria: Presence of an active skin condition or infection in the treatment area such as sores, Psoriasis, eczema, rash, severe active inflammatory acne or oral herpes simplex breakout. History of skin disorders, keloid scarring, and/or abnormal wound healing. Open wounds or lesions in the area(s) to be treated. Inability to understand the protocol or to give informed consent. History of chronic drug or alcohol abuse. History of vascular disease. History of bleeding disorders. BMI equal to or greater than 30. Subjects who are pregnant, nursing, or anticipate a pregnancy during the length of the trial. Subjects with current skin cancer or other malignant disease including pre-malignant moles. Poorly controlled medical condition that could compromise wound healing or increase risk of infection such as an impaired immune system due to immunosuppressive diseases such as AIDS and HIV, or use of immunosuppressive medications, radiation therapy, or chemotherapy. Subjects with implanted medical devices: pacemaker, cardioverts, superficial metal within the treatment area, and other implantable devices or synthetic fillers. Subjects with sensitivity or allergy to gold. Subjects with sensitivity or allergy to local anesthetics such as lidocaine or tetracaine. Concurrent enrollment in any study involving the use of investigational devices or drugs. History of surgical or cosmetic treatments in the area(s) to be treated within the past six months. History or current use of the following prescription medications: Daily anticoagulants, aspirin, iron supplements, herbal supplements such as ginkgo, ginseng or garlic within the past two weeks; Topical retinoid within the past one week; and Psychiatric drugs that in the investigators opinion would impair the subject from understanding the protocol requirements or understanding and signing the informed consent.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Prospective, non-randomized, open label
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Genius System Neck Treatment<br>Lutronic Genius System treatment of lines, wrinkles, and texture concerns on the neck. | Device: Lutronic Genius System<br>* Treatment of the neck using the Lutronic Genius System<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Masked qualitative assessment of improvement | An assessment of paired pre- and post-treatment photographs will be conducted by blinded assessors evaluating for improvement in neck appearance from pre- to post-treatment. The assessors choose the photo they believe to be the post-treatment photo, i.e., Left photo or Right photo. | From baseline to 90 days following the last treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinician aesthetic improvement | Overall aesthetic improvement based on completion of the Clinician Global Aesthetic Improvement Scale, a 5-point scale (0-4) that rates global aesthetic improvement from the pre-treatment appearance with 4 being 'Very Much Improved' and 0 being 'Worse'. The scale will be administered based on a live assessment of the subject while referring to the subject's pre-treatment photographs, and based on a comparison of the subject's pre-treatment photographs to the Day 90 follow-up photographs. | From baseline to Days 90 following the last study treatment. | 
| Subject aesthetic improvement | Overall aesthetic improvement based on completion of the Subject Global Aesthetic Improvement Scale, a 5-point scale (0-4) that rates global aesthetic improvement from the pre-treatment appearance with 4 being 'Very Much Improved' and 0 being 'Worse'. Subjects will complete the scale based on a live assessment while referring to a hand mirror and their pre-treatment photographs, and based on a comparison of their pre-treatment photographs to their Day 90 follow-up photographs. | From baseline to Days 90 following the last study treatment. | 
| Patient Satisfaction | Patient satisfaction will be evaluated based on subjects' completion of a patient satisfaction questionnaire while referring to a hand mirror and their pre-treatment and their Day 90 follow-up photographs. | From baseline to 90 days following the last study treatment | 
| Treatment-related pain | During each study treatment, subjects' pain levels will be monitored using a validated Numeric Rating Scale (0-10), with 0 being 'No Pain' and 10 being 'Worse Possible Pain'. | For the duration of each study treatment which typically can last up to approximately 90 minutes. |