Clinical trial NCT06089759: Performance and Safety of the Lipo-transfer Cannulas in Patients Underlying Lipofilling Treatment
Official title: Performance and Safety of the Lipo-transfer Cannulas in Patients Underlying Lipofilling Treatment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lipodystrophy
Deformities
Keywords: Lipofilling
Liposuction
Fat injection
Repair and aesthetic surgery
Aesthetic body contouring
Lead sponsor: Aesthetic Group
Sponsor class: INDUSTRY
Collaborators: name: EVAMED
First posted: 2023-10-18
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population is directly linked to target population for autograft with Aesthetic group's cannulas

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.


Eligibility criteria: 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

Primary outcomes:
measure: The performance of the cannulas for infiltration, fat harvesting or fat injection.
timeFrame: D0 (at intervention)
Secondary outcomes:
measure: The surgeon's satisfaction with the procedure
timeFrame: D0 (at intervention)
measure: The safety of the cannulas during the intervention (All adverse device effects occurred during the intervention will be summarized)
timeFrame: D0 (at intervention)
measure: 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)
timeFrame: D0 (at intervention) to month 1
measure: The usability of the cannulas during the intervention
timeFrame: D0 (at intervention)
measure: The quality of life
timeFrame: At baseline and 1 month follow-up
measure: The patient's satisfaction at 1 month (binary variable)
timeFrame: At 1 month
measure: The surgeon's satisfaction at 1 month
timeFrame: At 1 month
measure: The improvement of skin quality/aesthetic (likert scale)
timeFrame: At 1 month
Other outcomes:
Locations:
city: Brest
country: France
facility: Clinique Pasteur
city: Marseille
country: France
facility: Clinique Phenicia
city: Paris
country: France
facility: Clinique Eiffel
Study officials:
References: