LiposuctionAVE001NCT06791564
Minimally Invasive Active Release of Septa Bands for Cellulite and Connective Tissue Release for Fibrosis Treatment in Body Contouring Surgery
A study testing AVELI in people with Liposuction and Cellulite, run by Total Definer Research Group at 2 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Liposuction, Cellulite, Cellulite Reduction
- What is being tested?
- AVELI
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 15 Jan 2024to 1 Mar 2026
- Phase
- Interventional
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients undergoing HDL between 18 and 60 years old.
- Non-gender specific.
- American Association of Anesthesiologist Risk Assessment (ASA) ≤ 2.
- Body Mass Index (BMI) ≥20 and ≤ 32 kg/m2.
- Patients with any degree of clinically evident cellulite in any body area.
- Patients with prior liposuction procedures with any degree of fibrosis in any body area.
- Patients undergoing additional procedures such as, but not limited to: Rhinoplasty, Mammaplasty, Mastopexy, mini tummy tuck, full tummy tuck, brachioplasty, thighplasty, fat grafting. The procedure could not be related to the treatment of fibrosis or cellulite.
Who cannot join
- Patients requiring SQ fat grafting for the amendment of any contour irregularity.
- Patients requiring other devices/drugs for skin contraction and/or cellulite treatment for the next 6 months (RF, US, Enzymes, etc.).
- Patients undergoing Face Lift procedures.
- Patients with any history of abnormal scarring and/or hypertrophic scars and or keloids.
- Patients with Caprini score ≥ 8.
- Patients with past medical history of connective tissue disease with active disease and/or recent relapse.
Show all 14Show fewer
- Patients with past medical history thromboembolic disease or any other condition with an increased risk of coagulopathy (i.e., SLE, RA, APS).
- Patients using aspirin or any anticoagulant within 14 days and 5 days prior to surgery, respectively.
- Patients with a PMH of epilepsy or any epileptic syndrome and or vascular disease.
- Patients with any chronic disease non-compliant with treatment or non-adequately controlled.
- Positive pregnancy test or planning on getting pregnant in the next 6 months.
- Patients with fever or any other symptoms/signs of infection.
- Active smokers or chronic smokers with recent quit (≤ 4-8 weeks).
- Patients with prothrombin time (PT) and/or activated partial thromboplastin time (aPTT) >1.5 times baseline.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
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:
Read more
- Does AVELI safely reduce cellulite and fibrotic tissue without causing serious adverse events?
- How effective is AVELI in improving patient-reported outcomes and aesthetic appearance?
Through this study, the study team aims to evaluate the safety and effectiveness of AVELI.
The study procedures include:
- Baseline data collection of sociodemographic variables. Data collection of surgical variables, adverse events, and satisfaction scores.
- All patients will undergo the standardized High-Definition Liposculpture technique, with AVELI applied to all identified cellulite and/or fibrosis release.
- Photographic and 3D imaging preoperatively and at follow-ups (1, 3, 6, and 9 months).
Read the detailed description
Study design: Interventional prospective cohort study, non-randomized, non-controlled, no masking.
Ethical Considerations:
- IRB Approval: The study will adhere to the Declaration of Helsinki principles and will be approved by an Institutional Review Board (IRB).
- Informed Consent: Participants will be provided comprehensive information about study procedures, risks, and benefits, and written consent will be obtained.
- Data Confidentiality: All participant data will be anonymized and securely stored.
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:
- Dhara Clinic (Bogota, Colombia)
- Miami Aesthetic Center (Miami, FL - USA)
Data Collection:
- Demographic, Clinical, and surgical variables are going to be collected in an Excel-based password protected database.
- Other procedure related variables are also going to be collected in the same database, including pain assessment in the immediate postoperative, hemoglobin and hematocrit levels, time to discharge, and complications \& management.
- 3D photographic analysis will be employed to analyze preoperative, and postoperative images at 1, 3, 6 and 9 months post procedure. Then the changes will be objectively compared using Quantificare Photographical Software, through the different timepoints to evaluate the objective contour defects and postoperative improvement changes.
- Satisfaction Scores: Global Aesthetic Improvement Scale (GAIS) evaluated at least 3 months postoperatively.
- Conditions
- Liposuction, Cellulite, Cellulite Reduction, Fibrosis; Skin
- Being tested
- AVELI
- Keywords
- Aveli, Body contouring, Liposuction, Liposculpture, Cellulite reduction, Fibrosis Reduction, Fibrotic tissue
- Medical subject headings
- Cellulite, Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AVELIDevice
Minimally invasive method for selectively identifying and manually releasing specific septa responsible for causing cellulite depressions.
| Study group | Role | What they receive |
|---|---|---|
| Cellulite group (CG) | Experimental | Patients with any degree of clinically evident cellulite undergoing HDL + AVÉLI treatment for Cellulite. Receives: Device: AVELI |
| Fibrosis Group (FG) | Experimental | Patients with any degree of fibrosis undergoing non-primary HDL + AVÉLI release of fibrotic tissue. Receives: Device: AVELI |
| Fibrosis and Cellulite Group (FCG) | Experimental | Patients with any degree of clinically evident cellulite AND fibrosis undergoing non-primary HDL + AVÉLI treatment for both. Receives: Device: AVELI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: One month, three months, six months, and nine months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2025
- Study start15 Jan 2024
- Primary completion30 Dec 2025
- Study completion1 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for LiposuctionStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- All the participants are categorized into the 3 different intervention groups based on the individual pre-procedure physical exam by the plastic surgeon. Once in the study group, the patient receives the intervention corresponding to this arm of the study.
- Masking
- None (open label)
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Total Definer Research Group
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alfredo Hoyos, Total Definer Research Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06791564
- Sponsor's protocol ID
- Aveli
- Acronym
- AVE001
- Status last verified
- Apr 2026
- First submitted
- 19 Jan 2025
- Last updated
- 28 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Depending upon reasonable request
Publications
Stevens WG, Green JB, Layt C, Kaminer MS, Harrington J, Fan L, Wall HC, Fabi S, Magnusson MR. Multicenter Pivotal Study Demonstrates Safety and Efficacy of a New Cellulite Procedure: Final Results at 12 Months. Aesthet Surg J. 2023 Mar 15;43(4):455-466. doi: 10.1093/asj/sjac291.
PubMed 36351188Stevens WG, Kaminer MS, Fabi SG, Fan L. Study of a New Controlled Focal Septa Release Cellulite Reduction Method. Aesthet Surg J. 2022 Aug 1;42(8):937-945. doi: 10.1093/asj/sjac010.
PubMed 35089992Danilla S, Babaitis RA, Jara RP, Quispe DA, Andrades PR, Erazo CA, Albornoz CR, Sepulveda SL. High-Definition Liposculpture: What are the Complications and How to Manage Them? Aesthetic Plast Surg. 2020 Apr;44(2):411-418. doi: 10.1007/s00266-019-01475-6. Epub 2019 Aug 20.
PubMed 31432229Bass LS, Kaminer MS. Insights Into the Pathophysiology of Cellulite: A Review. Dermatol Surg. 2020 Oct;46 Suppl 1(1):S77-S85. doi: 10.1097/DSS.0000000000002388.
PubMed 32976174Friedmann DP, Vick GL, Mishra V. Cellulite: a review with a focus on subcision. Clin Cosmet Investig Dermatol. 2017 Jan 7;10:17-23. doi: 10.2147/CCID.S95830. eCollection 2017.
PubMed 28123311Gabriel A, Chan V, Caldarella M, Wayne T, O'Rorke E. Cellulite: Current Understanding and Treatment. Aesthet Surg J Open Forum. 2023 Jun 21;5:ojad050. doi: 10.1093/asjof/ojad050. eCollection 2023.
PubMed 37424836Ferry AM, Chamata E, Dibbs RP, Rappaport NH. Avoidance and Correction of Deformities in Body Contouring. Semin Plast Surg. 2021 May;35(2):110-118. doi: 10.1055/s-0041-1727207. Epub 2021 Jun 8.
PubMed 34121946
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Minimally Invasive Active Release of Septa Bands for Cellulite and Connective Tissue Release for Fibrosis Treatment in Body Contouring Surgery
- ClinicalTrials.gov ID
- NCT06791564
- Acronym / sponsor ID
- AVE001 / Aveli
- Conditions
- Liposuction, Cellulite, Cellulite Reduction, Fibrosis; Skin
- Keywords
- Aveli, Body contouring, Liposuction, Liposculpture, Cellulite reduction, Fibrosis Reduction, Fibrotic tissue
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Total Definer Research GroupUniversity, hospital or other
- Study start
- 15 Jan 2024 (actual)
- Primary completion
- 30 Dec 2025 (actual)
- Study completion
- 1 Mar 2026 (actual)
- First posted
- 24 Jan 2025 (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.
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:
- Does AVELI safely reduce cellulite and fibrotic tissue without causing serious adverse events?
- How effective is AVELI in improving patient-reported outcomes and aesthetic appearance?
Through this study, the study team aims to evaluate the safety and effectiveness of AVELI.
The study procedures include:
- Baseline data collection of sociodemographic variables. Data collection of surgical variables, adverse events, and satisfaction scores.
- All patients will undergo the standardized High-Definition Liposculpture technique, with AVELI applied to all identified cellulite and/or fibrosis release.
- Photographic and 3D imaging preoperatively and at follow-ups (1, 3, 6, and 9 months).
Detailed description
Study design: Interventional prospective cohort study, non-randomized, non-controlled, no masking.
Ethical Considerations:
- IRB Approval: The study will adhere to the Declaration of Helsinki principles and will be approved by an Institutional Review Board (IRB).
- Informed Consent: Participants will be provided comprehensive information about study procedures, risks, and benefits, and written consent will be obtained.
- Data Confidentiality: All participant data will be anonymized and securely stored.
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:
- Dhara Clinic (Bogota, Colombia)
- Miami Aesthetic Center (Miami, FL - USA)
Data Collection:
- Demographic, Clinical, and surgical variables are going to be collected in an Excel-based password protected database.
- Other procedure related variables are also going to be collected in the same database, including pain assessment in the immediate postoperative, hemoglobin and hematocrit levels, time to discharge, and complications \& management.
- 3D photographic analysis will be employed to analyze preoperative, and postoperative images at 1, 3, 6 and 9 months post procedure. Then the changes will be objectively compared using Quantificare Photographical Software, through the different timepoints to evaluate the objective contour defects and postoperative improvement changes.
- Satisfaction Scores: Global Aesthetic Improvement Scale (GAIS) evaluated at least 3 months postoperatively.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- All the participants are categorized into the 3 different intervention groups based on the individual pre-procedure physical exam by the plastic surgeon. Once in the study group, the patient receives the intervention corresponding to this arm of the study.
| Arm | Type | Receives |
|---|---|---|
| Cellulite group (CG) | Experimental | Device: AVELIPatients with any degree of clinically evident cellulite undergoing HDL + AVÉLI treatment for Cellulite. |
| Fibrosis Group (FG) | Experimental | Device: AVELIPatients with any degree of fibrosis undergoing non-primary HDL + AVÉLI release of fibrotic tissue. |
| Fibrosis and Cellulite Group (FCG) | Experimental | Device: AVELIPatients with any degree of clinically evident cellulite AND fibrosis undergoing non-primary HDL + AVÉLI treatment for both. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Patients undergoing HDL between 18 and 60 years old.
- Non-gender specific.
- American Association of Anesthesiologist Risk Assessment (ASA) ≤ 2.
- Body Mass Index (BMI) ≥20 and ≤ 32 kg/m2.
- Patients with any degree of clinically evident cellulite in any body area.
Key exclusion criteria (14 listed)
- Patients requiring SQ fat grafting for the amendment of any contour irregularity.
- Patients requiring other devices/drugs for skin contraction and/or cellulite treatment for the next 6 months (RF, US, Enzymes, etc.).
- Patients undergoing Face Lift procedures.
- Patients with any history of abnormal scarring and/or hypertrophic scars and or keloids.
- Patients with Caprini score ≥ 8.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AVELIMinimally invasive method for selectively identifying and manually releasing specific septa responsible for causing cellulite depressions. | Device | Cellulite group (CG), Fibrosis Group (FG), Fibrosis and Cellulite Group (FCG) |
Primary outcome
Serious Adverse Events Incidence
Time frame: 30 days
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.
Patient Satisfaction Scores
Time frame: 6 months
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.
Photographic aesthetic outcomes analysis
Time frame: One month, three months, six months, and nine months
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.
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 28 Apr 2026.
- Background: PubMed 36351188Stevens WG, Green JB, Layt C, Kaminer MS, Harrington J, Fan L, Wall HC, Fabi S, Magnusson MR. Multicenter Pivotal Study Demonstrates Safety and Efficacy of a New Cellulite Procedure: Final Results at 12 Months. Aesthet Surg J. 2023 Mar 15;43(4):455-466. doi: 10.1093/asj/sjac291.
- Background: PubMed 35089992Stevens WG, Kaminer MS, Fabi SG, Fan L. Study of a New Controlled Focal Septa Release Cellulite Reduction Method. Aesthet Surg J. 2022 Aug 1;42(8):937-945. doi: 10.1093/asj/sjac010.
- Background: PubMed 31432229Danilla S, Babaitis RA, Jara RP, Quispe DA, Andrades PR, Erazo CA, Albornoz CR, Sepulveda SL. High-Definition Liposculpture: What are the Complications and How to Manage Them? Aesthetic Plast Surg. 2020 Apr;44(2):411-418. doi: 10.1007/s00266-019-01475-6. Epub 2019 Aug 20.
- Background: PubMed 32976174Bass LS, Kaminer MS. Insights Into the Pathophysiology of Cellulite: A Review. Dermatol Surg. 2020 Oct;46 Suppl 1(1):S77-S85. doi: 10.1097/DSS.0000000000002388.
- Background: PubMed 28123311Friedmann DP, Vick GL, Mishra V. Cellulite: a review with a focus on subcision. Clin Cosmet Investig Dermatol. 2017 Jan 7;10:17-23. doi: 10.2147/CCID.S95830. eCollection 2017.
- Background: PubMed 37424836Gabriel A, Chan V, Caldarella M, Wayne T, O'Rorke E. Cellulite: Current Understanding and Treatment. Aesthet Surg J Open Forum. 2023 Jun 21;5:ojad050. doi: 10.1093/asjof/ojad050. eCollection 2023.
- Background: PubMed 34121946Ferry AM, Chamata E, Dibbs RP, Rappaport NH. Avoidance and Correction of Deformities in Body Contouring. Semin Plast Surg. 2021 May;35(2):110-118. doi: 10.1055/s-0041-1727207. Epub 2021 Jun 8.
- Individual participant dataSharing planned: Yes. Depending upon reasonable request
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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.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AVELI in people with Liposuction and Cellulite, run by Total Definer Research Group at 2 sites in 2 countries.
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 7 inclusion and 14 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 28 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Colombia. 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?
Serious Adverse Events Incidence (time frame: 30 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06791564, which also lists 7 linked publications.
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 28 Apr 2026.