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

NCT ID: NCT06089759

Last Updated: 2024-08-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

108 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-08-30

Study Completion Date

2024-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Lipodystrophy Deformities

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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EVAMED

OTHER

Sponsor Role collaborator

Aesthetic Group

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Clinique Pasteur

Brest, , France

Site Status

Clinique Phenicia

Marseille, , France

Site Status

Clinique Eiffel

Paris, , France

Site Status

Countries

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France

Other Identifiers

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LIPOTRANSFER

Identifier Type: -

Identifier Source: org_study_id

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