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NCT06791564 · ClinicalTrials.gov registry record · NA
Minimally Invasive Active Release of Septa Bands for Cellulite and Connective Tissue Release for Fibrosis Treatment in Body Contouring Surgery
A NA study of Cellulite and Liposuction, sponsored by Total Definer Research Group.
- Recruiting
- Registry status
- NA
- Development phase
- 150
- Enrollment target
- 2
- Study locations
NCT06791564: Recruiting NA study of Cellulite and Liposuction, sponsored by Total Definer Research Group.
NCT06791564 is a NA study of Cellulite and Liposuction that is actively recruiting participants, run by Total Definer Research Group. The registered enrollment target is 150 participants, roughly in line with the 142-participant average among 5 other Cellulite trials with a reported enrollment target. The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06791564, a NA study of Cellulite and Liposuction, is actively recruiting participants, sponsored by Total Definer Research Group.
- RECRUITING
- Registry status
- NA
- Development phase
- 150 participants
- Enrollment target
- 2
- Study locations
Study 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. 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).
Primary Outcome
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.
Conditions Studied
Interventions
- DEVICE AVELI
Study Locations (2)
Florida
- Miami Aesthetic - Miami
DC
- Dhara Clinic - Bogotá
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2024-01-15 |
| Est. Completion | 2025-12-15 |
| Phase | NA |
What NCT06791564 shows while recruiting
NCT06791564 is an interventional study that assigns participants to a tested intervention. The registered 150 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 142-participant average among 5 other Cellulite trials with a reported enrollment target.
The record links to 4 conditions, with Cellulite appearing as the primary indexed condition, and to 1 intervention - of which AVELI is the first listed.
NCT06791564 reports a single indexed study location in Florida, DC.
Frequently Asked Questions
What is clinical trial NCT06791564 about?
NCT06791564 is a clinical study titled "Minimally Invasive Active Release of Septa Bands for Cellulite and Connective Tissue Release for Fibrosis Treatment in Body Contouring Surgery". 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 q...
What is the current status of trial NCT06791564?
This trial is currently recruiting. It is a NA study. The enrollment target is 150 participants. The study started on 2024-01-15. Estimated completion is 2025-12-15.
What conditions does trial NCT06791564 study?
This clinical trial studies the following conditions: Cellulite, Liposuction, Cellulite Reduction, Fibrosis; Skin.
What interventions are being tested in trial NCT06791564?
The interventions under investigation include: AVELI (DEVICE).
Who is sponsoring clinical trial NCT06791564?
This trial is sponsored by Total Definer Research Group, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06791564 being conducted?
This trial has 2 study locations across Florida, DC. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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