An interventional study of AVELI in Liposuction, Cellulite and Cellulite Reduction, sponsored by Total Definer Research Group. Completed at 2 sites in 2 countries. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-04-28.
Sponsored by Total Definer Research Group · Not applicable, Interventional, and Treatment
This prospective study aims to evaluate the safety and effectiveness of AVELI for reducing cellulite and fibrotic tissue in patients undergoing High-Definition Liposculpture, exploring if AVELI improves the aesthetic outcomes, and reduced the clinically evident cellulite and/or fibrosis.
The main questions this study seeks to answer are:
Through this study, the study team aims to evaluate the safety and effectiveness of AVELI.
The study procedures include:
Study design: Interventional prospective cohort study, non-randomized, non-controlled, no masking.
Ethical Considerations:
Eligible patients will be approached, the study aims, objectives, procedures, and voluntary participation will be explained. In case patient consent to participate, a written informed consent will be signed. The patients will be comprehensively evaluated by the plastic surgeon, and assigned to a group based on their individual physical evaluation findings: Cellulite Group, Fibrosis Group, Fibrosis and Cellulite Group.
Study Locations:
Data Collection:
71 studies on the registry are indexed under Cellulite; 3 are open to participants now.
This study's enrollment of 130 is above the median of 34 across 65 interventional studies indexed under Cellulite.
Browse Cellulite studies →Total Definer Research Group is the lead sponsor of 6 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients with any degree of clinically evident cellulite undergoing HDL + AVÉLI treatment for Cellulite.
Device: AVELI
Patients with any degree of fibrosis undergoing non-primary HDL + AVÉLI release of fibrotic tissue.
Device: AVELI
Patients with any degree of clinically evident cellulite AND fibrosis undergoing non-primary HDL + AVÉLI treatment for both.
Device: AVELI
Minimally invasive method for selectively identifying and manually releasing specific septa responsible for causing cellulite depressions.
Serious Adverse Events Incidence
Incidence of intervention-related serious adverse events (SAE). SAE were defined as any adverse events that met one or more of the following criteria: required hospital care, required additional medical intervention or treatment, produced any disability, were classified as life-threatening, or resulted in the death of the patient.
Time frame: 30 days
Patient Satisfaction Scores
Patient-reported satisfaction scores measured using Global Aesthetic Improvement Scale (GAIS) for the reduction of cellulite and/or fibrosis. The GAIS is a standardized scale used primarily in cosmetic and dermatological treatments to assess the overall aesthetic improvement of a patient after a procedure. It consist of three questions: * how do you feel about your appearance after surgery? Possible answers: Very much improved, much improved, slightly improved, no change. * Are you satisfied with the surgery? Very satisfied, satisfied, not satisfied. * Would you recommend the surgical procedure? Possible answers: Yes, perhaps, no.
Time frame: 6 months
Photographic aesthetic outcomes analysis
Through 3D camera photos and photographic software, an analysis will objectively calculate the differences between preoperative contour defects (fibrosis and/or cellulite) and postoperative improvement.
Time frame: One month, three months, six months, and nine months
Plan to share: Yes — Depending upon reasonable request
Supporting information: Study protocol, Statistical analysis plan
Time frame: After results publication (manuscript)
Access criteria: Request to the main author
Ran from Jan 2024 to primary completion in Dec 2025, 23 months.
Of 20 interventional studies with no phase under Cellulite, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 14. This study's 23 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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Total Definer Research Group