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OpenTrials
Completed

NCT Number: NCT06089759

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Clinique Pasteur, Brest, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. The performance of the cannulas for infiltration, fat harvesting or fat injection.

    Time frame: D0 (at intervention)

    The success rate of cannulas defined by the capacity to infiltrate, harvest or inject.

Secondary outcomes

  1. The surgeon's satisfaction with the procedure

    Time frame: D0 (at intervention)

    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.

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

    Time frame: D0 (at intervention)

    All adverse device effects occurred during the intervention

  3. 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)

    Time frame: D0 (at intervention) to month 1

    All adverse events occurred from the intervention to the 1 month follow-up visit

  4. The usability of the cannulas during the intervention

    Time frame: D0 (at 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.

  5. The quality of life

    Time frame: At baseline and 1 month follow-up

    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

  6. The patient's satisfaction at 1 month (binary variable)

    Time frame: At 1 month

    The proportion of patients who are satisfied at 1 month (binary variable, yes or no, yes is the best value)

  7. The surgeon's satisfaction at 1 month

    Time frame: At 1 month

    The proportion of patients for whom the surgeon is satisfied at 1 month

  8. The improvement of skin quality/aesthetic (likert scale)

    Time frame: At 1 month

    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)

Sponsors and collaborators

Lead sponsor

Aesthetic Group

Industry

Collaborators

  • EVAMED

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Oct 18, 2023
Registry last updated
Aug 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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