RECRUITING

Minimally Invasive Active Release of Septa Bands for Cellulite and Connective Tissue Release for Fibrosis Treatment in Body Contouring Surgery

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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).

Official Title

Minimally Invasive Active Release of Septa Bands for Cellulite and Connective Tissue Release for Fibrosis Treatment in Body Contouring Surgery

Quick Facts

Study Start:2024-01-15
Study Completion:2025-12-15
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06791564

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 60 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patients undergoing HDL between 18 and 60 years old.
  2. * Non-gender specific.
  3. * American Association of Anesthesiologist Risk Assessment (ASA) ≤ 2.
  4. * Body Mass Index (BMI) ≥20 and ≤ 32 kg/m2.
  5. * Patients with any degree of clinically evident cellulite in any body area.
  6. * Patients with prior liposuction procedures with any degree of fibrosis in any body area.
  7. * 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.
  1. * Patients requiring SQ fat grafting for the amendment of any contour irregularity.
  2. * Patients requiring other devices/drugs for skin contraction and/or cellulite treatment for the next 6 months (RF, US, Enzymes, etc.).
  3. * Patients undergoing Face Lift procedures.
  4. * Patients with any history of abnormal scarring and/or hypertrophic scars and or keloids.
  5. * Patients with Caprini score ≥ 8.
  6. * Patients with past medical history of connective tissue disease with active disease and/or recent relapse.
  7. * Patients with past medical history thromboembolic disease or any other condition with an increased risk of coagulopathy (i.e., SLE, RA, APS).
  8. * Patients using aspirin or any anticoagulant within 14 days and 5 days prior to surgery, respectively.
  9. * Patients with a PMH of epilepsy or any epileptic syndrome and or vascular disease.
  10. * Patients with any chronic disease non-compliant with treatment or non-adequately controlled.
  11. * Positive pregnancy test or planning on getting pregnant in the next 6 months.
  12. * Patients with fever or any other symptoms/signs of infection.
  13. * Active smokers or chronic smokers with recent quit (≤ 4-8 weeks).
  14. * Patients with prothrombin time (PT) and/or activated partial thromboplastin time (aPTT) \>1.5 times baseline.

Contacts and Locations

Study Contact

Alfredo Hoyos, MD
CONTACT
+13059154274
alhoyos@gmail.com
Mauricio Perez, MD
CONTACT
meperezmd@gmail.com

Study Locations (Sites)

Miami Aesthetic
Miami, Florida, 33131
United States

Collaborators and Investigators

Sponsor: Total Definer Research Group

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-01-15
Study Completion Date2025-12-15

Study Record Updates

Study Start Date2024-01-15
Study Completion Date2025-12-15

Terms related to this study

Keywords Provided by Researchers

  • Aveli
  • Body contouring
  • Liposuction
  • Liposculpture
  • Cellulite reduction
  • Fibrosis Reduction
  • Fibrotic tissue

Additional Relevant MeSH Terms

  • Liposuction
  • Cellulite
  • Cellulite Reduction
  • Fibrosis; Skin