Evaluation of Efficacy and Safety of the triLift™ System

Study Overview
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Brief Summary
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Single center, single-arm, prospective, open Label with Before & After Study Design.

Detailed Description
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Single center, single-arm, prospective, open Label with Before & After Study Design. The control group will be the subjects before the triLift™ treatment protocol and the experimental group will consist of the same subjects after completion of the triLift™ treatment protocol.

Official Title
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Evaluation of Efficacy and Safety of the triLift™ System

Conditions
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Skin Laxity, Wrinkle

Intervention / Treatment
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* Device: triLift system


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is willing and able to read, understand, and sign the informed consent. Healthy male or female aged 35 - 55 years. Fitzpatrick skin type 1-6. Subject is capable of reading, understanding, and following instructions of the procedure to be applied. Subject is able and willing to comply with the treatment. Women in childbearing age who is willing to conduct a pregnancy test prior to each treatment. Exclusion Criteria: Pregnant, lactating, or plans to become pregnant during the study period or had given birth less than 6 months ago. Concurrent participation in any other study. Subject has a pacemaker or internal defibrillator, implanted neurostimulators or any other internal electric device or patient who had an implant in the past. Subject has metal or other implants in the treatment area (Not including dental fillings, implants and crowns). Subject has significant concurrent skin conditions affecting areas to be treated such as sores, bleeding, skin fragility, eczema or psoriasis. Subject has burned, blistered, irritated, or sensitive skin due to excessive fresh tanning in areas to be treated or is unlikely to refrain from excessive tanning during the study. Subject has used oral isotretinoin (Accutane® or Roaccutan®) within 6 months prior to study. Subject has used topical retinoids in the past 1 month. History of systemic cancer; premalignant skin lesion or skin concern treatment area. Concurrent conditions such as epilepsy, autoimmune, pulmonary or cardiac disorders. Poorly controlled endocrine disorders such as diabetes. Impaired immune system due to immunosuppressive diseases such as HIV or AIDS, or use of immunosuppressive medications. History of collagen disorders, keloid formation or abnormal wound healing. Takes or has taken medications, herbal preparations, food supplements or vitamins that might cause fragile skin or impaired skin healing. Subject has used oral steroids in the past 6 months. Subject has used topical steroids in the past 3 months. History of bleeding coagulopathies or use of anticoagulants. Use of non-steroidal anti-inflammatory drugs (NSAIDS, e.g. ibuprofen containing agents) one week before and after each treatment session prior to treatment. Subjects who cannot feel heat to give proper treatment feedback. (nerve damage, etc.) Mental disorders that in the opinion of the Investigator would interfere with the ability to comply with the study requirements. Subject has any other medical condition that in the opinion of the Investigator warrants exclusion from this study.

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 55 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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Trilift system treatment arm<br>Single arm with Before & After photos, triLift treatment protocol study design. | Device: triLift system<br>* To evaluate the efficacy of the triLift™ treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Global Aesthetic Improvement scale (GAI) | The Global Aesthetic Improvement scale (GAI) - Success is defined as an improvement of at least 1 point on the GAI scale assessed by the investigator, at the end of the treatment protocol as compared to baseline. | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 3D images | Measuring facial lifting using 3D imaging and analysis algorithm from Quantificare before and after the treatment protocol | 4 months | 
| Comfort assessment | Subject assessment of pain and discomfort associated with treatments using a Pain Visual Analogue Scale (VAS), where 0 is no pain and 10 is worst pain possible | 3 months | 
| Subject level of Satisfaction | Subject satisfaction will be assessed using a 5 level satisfaction questionnaire. | 4 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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laxity, facial lifting, wrinkles, rhytids