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

Lipodystrophy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06089759
• Other study ID #: LIPOTRANSFER
• Status: Recruiting
• Start date: August 30, 2023
• Est. completion date: April 4, 2024

Study information

• Verified date: October 2023
• Source: Aesthetic Group
• Contact: Valérie BOQUET
• Phone: +33(3).44.74.19.95
• Email: v.boquet[@]aestheticgroup.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 108
• Est. completion date: April 4, 2024
• Est. primary completion date: February 29, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lipodystrophy

Locations

Country	Name	City	State
France	Clinique Pasteur	Brest
France	Clinique Phenicia	Marseille
France	Clinique Eiffel	Paris

Sponsors (2)

Lead Sponsor	Collaborator
Aesthetic Group	EVAMED

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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	D0 (at intervention)
Secondary	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
Secondary	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)
Secondary	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
Secondary	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
Secondary	The surgeon's satisfaction at 1 month	The proportion of patients for whom the surgeon is satisfied at 1 month	At 1 month
Secondary	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