RF and PEMF Following Liposuction

NCT03588702 | Completed

• 1 other identifier: CS0817
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The Venus Legacy LB2 Body applicator is intended for circumference reduction treatment by reducing fat cell size and enhancing collagen synthesis as the result of thermal and non-thermal collagen stimulation. This is an open-label, evaluator-blind study of the safety and performance of radiofrequency (RF) and pulsed electromagnetic field (PEMF) therapy following liposuction. The study will enroll up to 50 male and female subjects requesting treatment of the back, flanks and/or thighs to improve appearance following liposuction. Subjects will receive a total of six study treatments to one side of their body (back, flanks and/or thighs) at one week intervals. Subjects will be followed up at one month after their last study treatment. Treatment outcomes will be compared to the non-treated side.

Conditions

Lipolysis

Keywords

radiofrequency; pulsed electro-magnetic fields; liposuction

Outcome Measures

Primary Outcomes (1)

• Improvement in skin appearance of the treated side

  Using the General Aesthetic improvement scale (GAIS), blinded reviewers assess photos of liposuction area to determine improvement in treated side as compared to non-treated side where 3 is very much improved; 2 is much improved; 1 is imporved; 0 is no change; -1 is worse; -2 is much worse and -3 is very much worse.

  One month after last treatment

Secondary Outcomes (2)

• Improvement in skin elasticity of the treated side

  One month after last treatment

• Subject satisfaction of treatment

  One month after last treatment

Study Arms (1)

Venus Legacy LB2 Body applicator group

EXPERIMENTAL

Liposuction area is divided into 2 equal sections. One section receives RF and PEMF treatment.

Device: RF and PEMF treatment

Interventions

RF and PEMF treatment DEVICE

Treatment with Venus Legacy LB2 body applicator

Also known as: Venus Legacy LB2 Body applicator

Venus Legacy LB2 Body applicator group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy male or female older than 18 years of age but not older than 65 years of age.
• Having suitable area for treatment (bilateral liposuction of the back, flanks or thighs performed 8 weeks prior to study).
• BMI score is greater than 18.5 and less than 29.9.
• Willingness to refrain from a change in diet/drinking/exercise/medication regimen for the entire course of the study.

You may not qualify if:

• Pregnant or planning to become pregnant, having given birth (vaginal birth or Caesarean surgery) less than 9 months ago, and/or breastfeeding.
• Having any active electrical implant anywhere in the body, such as a pacemaker or an internal defibrillator.
• Having a permanent implant in the treated areas, such as metal plates and screws or an injected chemical substance.
• Having undergone any other surgery in the treated areas within 9 months of treatment or during the study.
• Having or undergoing any form of treatment for active cancer, or having a history of skin cancer or any other cancer in the areas to be treated, including presence of malignant or pre-malignant pigmented lesions.
• Suffering from significant concurrent illness, such as cardiac disorders, diabetes (type I or II), lupus, porphyria, or pertinent neurological disorders.
• Having a known anti-coagulative or thromboembolic condition or taking anticoagulation medications one week prior to and during the treatment course.
• History of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or currently using immunosuppressive medications.
• Suffering from hormonal imbalance which may affect weight or cellulite.
• History of significant lymphatic drainage problems.
• Suffering from significant skin conditions in the treated areas or inflammatory skin conditions, including, but not limited to, open lacerations or abrasions and active cold sores or herpes sores prior to treatment or during the treatment course.
• History of keloid scarring or of abnormal wound healing.
• History of being especially prone to bruising.
• History of epidermal or dermal disorders (particularly if involving collagen or micro-vascularity).
• Use of oral retinoids (e.g. isotretinoin (Accutane®)) within 6 months of treatment or during the study.

Sponsors & Collaborators

• Venus Concept: lead

Study Sites (1)

Ocean Clinic

Marbella, Spain

Location

Study Officials

• Paul Cardarelli

  Venus Concept

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Independent blinded reviewers to view photographs to assess improvement of skin appearance of the treated side at 1 month post-treatment using the General Aesthetic Improvement Scale (GAIS) compared to the non-treated side
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Subjects act as their own control.

Study Record Dates

• First Submitted: July 3, 2018
• First Posted: July 17, 2018
• Study Start: July 2, 2018
• Primary Completion: November 13, 2020
• Study Completion: November 13, 2020
• Last Updated: April 26, 2023

Record last verified: 2023-04

Locations

ES (1)