LipodystrophyNCT06089759
Performance and Safety of the Lipo-transfer Cannulas in Patients Underlying Lipofilling Treatment
An observational study of Lipodystrophy and Deformities, run by Aesthetic Group at 3 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lipodystrophy, Deformities
- How many people
- 108 participants
- Where
- 3 sitesFrance
- Study dates
- 30 Aug 2023to 31 Jul 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population is directly linked to target population for autograft with Aesthetic group's cannulas
Who may be able to join
- 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.
Who cannot join
- 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)
Show all 10Show fewer
- 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
Trial locations and contacts
3 sites in 1 country.
France3 sites
Clinique Pasteur
Brest, 29200
Clinique Phenicia
Marseille, 13005
Clinique Eiffel
Paris, 75116
About this study
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
- Medical subject headings
- Lipodystrophy, Congenital Abnormalities
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: D0 (at intervention)
Secondary outcomes (8)
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.
Measured: D0 (at intervention)
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
Measured: 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)
All adverse events occurred from the intervention to the 1 month follow-up visit
Measured: D0 (at intervention) to month 1
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.
Measured: D0 (at intervention)
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
Measured: At baseline and 1 month follow-up
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)
Measured: At 1 month
The surgeon's satisfaction at 1 month
The proportion of patients for whom the surgeon is satisfied at 1 month
Measured: At 1 month
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)
Measured: At 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2023
- Study start30 Aug 2023
- Primary completion1 Jul 2024
- Study completion31 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LipodystrophyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aesthetic Group
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- EVAMED
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06089759
- Sponsor's protocol ID
- LIPOTRANSFER
- Status last verified
- Jul 2024
- First submitted
- 21 Aug 2023
- Last updated
- 1 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Performance and Safety of the Lipo-transfer Cannulas in Patients Underlying Lipofilling Treatment
- ClinicalTrials.gov ID
- NCT06089759
- Acronym / sponsor ID
- LIPOTRANSFER
- Conditions
- Lipodystrophy, Deformities
- Keywords
- Lipofilling, Liposuction, Fat injection, Repair and aesthetic surgery, Aesthetic body contouring
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Aesthetic GroupIndustry (pharma, biotech, devices)
- Collaborators
- EVAMED
- Study start
- 30 Aug 2023 (actual)
- Primary completion
- 1 Jul 2024 (actual)
- Study completion
- 31 Jul 2024 (actual)
- First posted
- 18 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population is directly linked to target population for autograft with Aesthetic group's cannulas
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
8 secondary outcomes
The surgeon's satisfaction with the procedure
Time frame: D0 (at intervention)
The safety of the cannulas during the intervention (All adverse device effects occurred during the intervention will be summarized)
Time frame: 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)
Time frame: D0 (at intervention) to month 1
The usability of the cannulas during the intervention
Time frame: D0 (at intervention)
The quality of life
Time frame: At baseline and 1 month follow-up
The patient's satisfaction at 1 month (binary variable)
Time frame: At 1 month
The surgeon's satisfaction at 1 month
Time frame: At 1 month
The improvement of skin quality/aesthetic (likert scale)
Time frame: At 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lipodystrophy and Deformities, run by Aesthetic Group at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The performance of the cannulas for infiltration, fat harvesting or fat injection. (time frame: D0 (at intervention)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2024.