Status:
COMPLETED
Performance and Safety of the Lipo-transfer Cannulas in Patients Underlying Lipofilling Treatment
Lead Sponsor:
Aesthetic Group
Collaborating Sponsors:
EVAMED
Conditions:
Lipodystrophy
Deformities
Eligibility:
All Genders
18+ years
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 30 2023
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 31 2024
Estimated Enrollment :
108 Patients enrolled
Trial Details
Trial ID
NCT06089759
Start Date
August 30 2023
End Date
July 31 2024
Last Update
August 1 2024
Active Locations (3)
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1
Clinique Pasteur
Brest, France, 29200
2
Clinique Phenicia
Marseille, France, 13005
3
Clinique Eiffel
Paris, France, 75116