Deformities, Lipodystrophy
Conditions
Keywords
Lipofilling, Liposuction, Fat injection, Repair and aesthetic surgery, Aesthetic body contouring
Brief summary
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.
Interventions
None listed
Sponsors
EVAMED
Aesthetic Group
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The performance of the cannulas for infiltration, fat harvesting or fat injection. | D0 (at intervention) | The success rate of cannulas defined by the capacity to infiltrate, harvest or inject. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The safety of the cannulas during the intervention (All adverse device effects occurred during the intervention will be summarized) | D0 (at intervention) | All adverse device effects occurred during the 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) | D0 (at intervention) to month 1 | All adverse events occurred from the intervention to the 1 month follow-up visit |
| The usability of the cannulas during the intervention | D0 (at 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. |
| The surgeon's satisfaction with the procedure | D0 (at intervention) | 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. |
| The patient's satisfaction at 1 month (binary variable) | At 1 month | The proportion of patients who are satisfied at 1 month (binary variable, yes or no, yes is the best value) |
| The surgeon's satisfaction at 1 month | At 1 month | The proportion of patients for whom the surgeon is satisfied at 1 month |
| The improvement of skin quality/aesthetic (likert scale) | At 1 month | 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) |
| The quality of life | At baseline and 1 month follow-up | 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 |
Countries
France
Outcome results
None listed