Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| EVAMED | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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) |
| 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) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
The study population is directly linked to target population for autograft with Aesthetic group's cannulas
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinique Pasteur | Brest | 29200 | France | |||
| Clinique Phenicia |
Not provided
| ID | Term |
|---|---|
| D008060 | Lipodystrophy |
| D000013 | Congenital Abnormalities |
| ID | Term |
|---|---|
| D012875 | Skin Diseases, Metabolic |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D052439 | Lipid Metabolism Disorders |
Not provided
Not provided
Not provided
Not provided
Not provided
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 |
| Marseille |
| 13005 |
| France |
| Clinique Eiffel | Paris | 75116 | France |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |