Performance and Safety of the Lipo-transfer Cannulas in Patients Underlying Lipofilling Treatment (NCT06089759) | Clinical Trial Compass
CompletedNot Applicable
Performance and Safety of the Lipo-transfer Cannulas in Patients Underlying Lipofilling Treatment
France108 participantsStarted 2023-08-30
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The performance of the cannulas for infiltration, fat harvesting or fat injection.