Performance and Safety of the Lipo-transfer Cannulas in Patients Underlying Lipofilling Treatment

Study Overview
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Brief Summary
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The purpose of this post-market clinical follow up study is to assess the safety and performance of Aesthetic Group cannulas. The study will evaluate the outcome of the Aesthetic Group cannulas range over a period of 1 month after intervention.

Official Title
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Performance and Safety of the Lipo-transfer Cannulas in Patients Underlying Lipofilling Treatment

Conditions
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Lipodystrophy, Deformities

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient age ≥ 18 years at intervention Patient who will undergo a lipofilling treatment with at least one cannula of Aesthetic Group Patient informed of his/her participation and willing to participate in the study. Patient able to read, write and understand French. Exclusion Criteria: Patient deprived of freedom, under guardianship/curatorship or placed under judicial protection Patient unable to follow study procedures Patient with hematologic abnormalities, prior radiotherapy or chemotherapy Chronic use of medicines or drugs Patient with diabetes mellitus Patient with connective tissue diseases, any type of fat tissue disorder (lipodystrophy) Patient with bleeding disorders; immune deficits; heart, liver, and kidney insufficiency Patient with allergies to local anaesthetics Patient with pacemaker and serious heart rhythm disorders Pregnant and breastfeeding women

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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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The performance of the cannulas for infiltration, fat harvesting or fat injection. | The success rate of cannulas defined by the capacity to infiltrate, harvest or inject. | D0 (at intervention) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The surgeon's satisfaction with the procedure | The surgeon satisfaction will be assessed using a 4-point scale (likert scale) at intervention. (Very satisfied, Satisfied, Unsatisfied, Very unsatisfied). Very satisfied is the higher score and outcome. | D0 (at intervention) | 
| The safety of the cannulas during the intervention (All adverse device effects occurred during the intervention will be summarized) | All adverse device effects occurred during the intervention | D0 (at intervention) | 
| The safety of the intervention within the 1 month post intervention (All adverse events occurred from the intervention to the 1 month follow-up visit will be summarized) | All adverse events occurred from the intervention to the 1 month follow-up visit | D0 (at intervention) to month 1 | 
| The usability of the cannulas during the intervention | Usability of the cannulas (easy to fit, …) assessed with a questionnaire (Scale of ease of fitting the cannula) in by the investigator (Very satisfied, Satisfied, Unsatisfied, Very unsatisfied). Very satisfied is the best value and outcome. | D0 (at intervention) | 
| The quality of life | Improvement of QoL score (numeric scale, 0 to 10, 10 is the maximum and the best value, 0 is the minimum value) at 1 month compared with pre-operative visit | At baseline and 1 month follow-up | 
| The patient's satisfaction at 1 month (binary variable) | The proportion of patients who are satisfied at 1 month (binary variable, yes or no, yes is the best value) | At 1 month | 
| The surgeon's satisfaction at 1 month | The proportion of patients for whom the surgeon is satisfied at 1 month | At 1 month | 
| The improvement of skin quality/aesthetic (likert scale) | The proportion of patients where the skin quality/aesthetic is improved at each follow-up visit. (Good improvement, mild improvement, no improvement, worsening, good improvement is the best value and outcome, worsening is the minimum value) | At 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lipofilling, Liposuction, Fat injection, Repair and aesthetic surgery, Aesthetic body contouring