Performance and Safety of the Lipo-transfer Cannulas in Patients Underlying Lipofilling Treatment

NCT06089759 | Completed

• 1 other identifier: LIPOTRANSFER
• Study Type: observational
• Target: 108
• Locations: 1 country
• Sites: 3

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.

Conditions

Lipodystrophy; Deformities

Keywords

Lipofilling; Liposuction; Fat injection; Repair and aesthetic surgery; Aesthetic body contouring

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (8)

• The surgeon's satisfaction with the procedure

  D0 (at intervention)

• The safety of the cannulas during the intervention (All adverse device effects occurred during the intervention will be summarized)

  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)

  D0 (at intervention) to month 1

• The usability of the cannulas during the intervention

  D0 (at intervention)

• The quality of life

  At baseline and 1 month follow-up

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population is directly linked to target population for autograft with Aesthetic group's cannulas

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Aesthetic Group: lead
• EVAMED: collaborator

Study Sites (3)

Clinique Pasteur

Brest, 29200, France

Location

Clinique Phenicia

Marseille, 13005, France

Location

Clinique Eiffel

Paris, 75116, France

Location

MeSH Terms

Conditions

Lipodystrophy; Congenital Abnormalities

Condition Hierarchy (Ancestors)

Skin Diseases, Metabolic; Skin Diseases; Skin and Connective Tissue Diseases; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2023
• First Posted: October 18, 2023
• Study Start: August 30, 2023
• Primary Completion: July 1, 2024
• Study Completion: July 31, 2024
• Last Updated: August 1, 2024

Record last verified: 2024-07

Locations

FR (3)