Mechanical Coring to Achieve Directional Skin Tightening

Study Overview
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Brief Summary
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The objective of this clinical study is to evaluate the safety and efficacy of mechanical coring for directional skin tightening. This study is a prospective, up to 3 center, multiple skin treatment area study of the safety and efficacy of mechanical coring with directional closure to achieve directional skin tightening.

Detailed Description
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The study will evaluate the progress of up to 70 subjects after one treatment at up to 6 treatment areas on the body chosen from 2 on the neck (each treatment area approximately 1x3 cm), 2 on each underarm, 1 on each cheek, 2 on the abdomen, one on each thigh and 2 on the forehead area above the eyebrows (all approximately 6x4 cm). Subjects will be followed at 2, 5, 14, 28, 60, and 90 days after treatment.

Official Title
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Pilot Study for the Clinical Evaluation of Mechanical Coring to Achieve Directional Skin Tightening

Conditions
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Skin Tightening, Healthy Volunteers

Intervention / Treatment
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* Device: VENUS AIME (RoboCor)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy, male or female subjects between 30 and 70 years of age. Able to read, understand, and voluntarily provide written Informed Consent. Able and willing to comply with the treatment/follow-up schedule and requirements. Women of childbearing age are required to be using a reliable method of birth control at least 3 months prior to study enrollment and for the duration of the study and have a negative Urine Pregnancy test at baseline. Subjects may have any Fitzpatrick skin type, however, no more than 35% of subjects may have Fitzpatrick skin type V or VI. Exclusion Criteria: Previous aesthetic (device and/or surgical) skin treatment in the treated areas (under arms and/or behind the ear) in the previous 6 months. Fat, collagen, silicone, tattoos, body jewelry, that cannot be removed for the duration of treatment, and tegaderm/glue application or any other synthetic material in the treatment area. History of keloid formation Active smoker or having quit smoking in the last 3 months. Active, chronic, or recurrent infection Compromised immune and/or healing system (e.g. diabetes) Hypersensitivity/allergy to analgesic agents, Betadine, tumescent, Benzoin Tincture, Tegaderm or tensioning tape that will be used in the study. Co-morbid condition that could limit the ability to participate in the study or to comply with follow-up requirements. Pregnant or breastfeeding Any indication that may cause excessive bleeding, e.g., anticoagulants. Carcinoma, melanoma, or any other cancerous condition in the last 6 months. Allergy to adrenaline, epinephrine, or Tranexamic acid (TXA). Currently or in the last 1-month part of another clinical study of an investigational drug and/or experimental medical device Any issue that, at the discretion of the investigator would contra-indicate the subject's participation.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 70 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 |
| --- | --- |
| Experimental: Micro-coring treatment<br> | Device: VENUS AIME (RoboCor)<br>* VENUS AIME is a micro-coring device of the skin that can potentially help to reduce visible skin scarring, improve skin laxity and reduce wrinkles.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Cores Successfully Removed by Coring Device | Percentage of cores successfully removed by the coring device without manual removal. | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Downtime, as evaluated using the Subject Questionnaire | Made of 8 questions asking if subject felt self-conscious, covered up the treatment area, avoided people, unable to perform normal activities, felt pain, discomfort or itchiness. For each, the subject may answer 1) Not at all, 2) Some of the time, or 3) Most of the time. A lower score indicates a better result. | Up to Day 90 (end of study) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rhytides, Wrinkles, Loose Skin, Skin Laxity, Mechanical Coring, Robotic Coring, Skin Scarring, Scars, Stretch marks