An observational study in Lipodystrophy and Deformities, sponsored by Aesthetic Group. Completed at 3 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-08-01.
Sponsored by Aesthetic Group · Observational
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.
139 studies on the registry are indexed under Lipodystrophy; 10 are open to participants now.
This study's enrollment of 108 is close to the median of 104 across 34 observational studies indexed under Lipodystrophy.
Browse Lipodystrophy studies →This is the only study on the registry with Aesthetic Group as lead sponsor.
Counted across the registry records on this site, refreshed daily.
The study population is directly linked to target population for autograft with Aesthetic group's cannulas
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
Time frame: D0 (at intervention)
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.
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 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)
Time frame: At 1 month
The surgeon's satisfaction at 1 month
The proportion of patients for whom the surgeon is satisfied at 1 month
Time frame: 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)
Time frame: At 1 month
Ran from Aug 2023 to primary completion in Jul 2024, 10 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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