The Volumetric Analysis of Fat Grafting

Study Overview
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Brief Summary
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Title: The Volumetric Analysis of Fat Grafting for Aesthetic Body Contouring. Subjects who wish to undergo fat grafting for aesthetic body contouring will be offered enrollment to the study. The study will consist of a Screening/Baseline visit, Surgery day and 3 follow up visits. Each follow up visit will utilize Vectra 3D photography (Canfeild, NJ) to collect volumetric data. At the conclusion of the study, Volume data from Baseline and 3 follow up visits will be analyzed to determine fat retention rates.

Official Title
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The Volumetric Analysis of Fat Grafting for Aesthetic Body Contouring

Conditions
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Autologous Fat Grafting

Intervention / Treatment
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* Device: Revolve System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Females or Males in good general health age 18 - 65 years of age Must be willing to give and sign a HIPAA form and informed consent form Must be willing and able to comply with all study protocols and schedules Negative urine pregnancy test prior to surgery treatment (if applicable) The patient must have had a stable weight (no fluctuation of >15 pounds in a year), diet, and physical activity for the previous 6 months Exclusion Criteria: Pregnancy, currently breast feeding or planning pregnancy for the duration of the trial History of breast cancer if fat grafting to breasts Patients who smoke or use nicotine products Any UNCONTROLLED systemic disease -a potential patient in whom therapy for a systemic disease is not yet stabilized will not be considered for entry into the study Diabetes Mellitus Subject has a clinically significant coagulation disorder or disease, defined as a platelet count < 100,000 per microliter or International Normalized Ratio > 1.5 within 4 weeks of surgery Patients under the age of 18 Patients undergoing fat grafting but refuse enrollment Patients with an active infection Current participation or participation within 30 days prior to the start of this study in a drug or other investigational research study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Revolve System|Fat grafting system|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Graft retention | Vectra 3D volumetric analysis will be utilized to evaluate graft retention. | 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Volume of adipose harvested (mL) |  | Intra Op | 
| Volume of adipocyte injected (mL) |  | Intra Op | 
| Operating room time (harvesting, processing, and reinjection time) (min) |  | Intra Op | 
| Standardized before and after photos |  | Pre op, 3 months, 6 months, 9 months |