Last reviewed · How we verify
NCT06791564: AVE001
Minimally Invasive Active Release of Septa Bands for Cellulite and Connective Tissue Release for Fibrosis Treatment in Body Contouring Surgery
NA trial testing AVELI in Liposuction in 150 participants. Currently enrolling.
30 June 2025
Quick facts
| Lead sponsor | Total Definer Research Group |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 150 |
| Start date | 15 January 2024 |
| Primary completion | 30 June 2025 |
| Estimated completion | 15 December 2025 |
| Sites | 2 locations across Colombia, United States |
Drugs / interventions tested
- AVELI
Conditions studied
- Liposuction — all drugs for Liposuction →
- Cellulite — all drugs for Cellulite →
- Cellulite Reduction — all drugs for Cellulite Reduction →
- Fibrosis; Skin — all drugs for Fibrosis; Skin →
Sponsor
Total Definer Research Group
Who can join
Adults 18 to 60, any sex, with Liposuction or Cellulite. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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).
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06791564
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Liposuction
Currently open trials in the same condition.
- NCT06791577 — Bridging the Healing Gap: A Single-Blind Clinical Trial Assessing the Efficacy of Carboxy-gel in Reducing Bruising and P · Phase 4 · recruiting
Other Total Definer Research Group trials
Trials by the same sponsor.
- NCT06791577 — Bridging the Healing Gap: A Single-Blind Clinical Trial Assessing the Efficacy of Carboxy-gel in Reducing Bruising and P · Phase 4 · recruiting
- NCT06238739 — Optimal Temperature Control in Body Contouring Procedures · NA · completed
- NCT06648265 — EFFECTS OF TRANEXAMIC ACID IN TUMESCENT SOLUTION FOR LIPOSUCTION PROCEDURES · Phase 4 · completed
- NCT04430777 — Use of Tranexamic Acid in Liposculpture · Phase 2, PHASE3 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06791564 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Total Definer Research Group
- Last refreshed: 30 April 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06791564.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing