Clinical Evaluation of a 1060 nm Diode Laser, PEMF and Vacuum Assisted MP RF for Non-invasive Fat Reduction

NCT04012814 | Completed Results FDA Device

• 1 other identifier: BL0319
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 5

Brief Summary

Open-label, baseline-controlled, multi-center study evaluating a 1060 nm diode laser, pulsed electromagnetic fields and vacuum assisted radio frequency for non-invasive fat reduction of the abdomen and flanks.

Conditions

Adipose Tissue Atrophy

Keywords

fat; abdomen fat; flank fat; body contouring

Outcome Measures

Primary Outcomes (1)

• Change in Aesthetic Appearance From Baseline

  Photographic evaluation by an independent, blinded reviewer with correct identification of pre-treatment baseline images when compared to post-treatment images taken at Week 24 using the Global Aesthetic Improvement Scale (GAIS). A score of 0 is no change, 1 - slight change, 2 - moderate change, 3 - dramatic change. An incorrect identification would result in a negative score (-1 for slight, -2 for moderate and -3 for dramatic change)

  Week 24

Secondary Outcomes (2)

• Subject Satisfaction: 5-Point Likert Subject Satisfaction Scale

  Week 24

• Change in Fat Thickness

  Week 24

Study Arms (1)

Subject treatment group

EXPERIMENTAL

Treatment group receiving 3 diode treatments and 3 RF/PEMF treatments at Week 0, 8 and 16 with a follow-up at Week 24.

Device: Venus Bliss

Interventions

Venus Bliss DEVICE

The FDA cleared device (Venus Bliss™) is a non-invasive medical aesthetic device designed for body contouring. The device is comprised of a console, four 1060 nm diode laser applicators (60 mm x 60 mm). A belt is included to allow the operator to secure the laser applicators on the lipolysis treatment area, allowing hands free operation. The device uses vacuum assisted radiofrequency (RF) and PEMF (pulsed electromagnetic field) technology which has been shown in clinical studies to be safe and effective in body circumferential reduction and skin tightening.

Subject treatment group

Eligibility Criteria

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

You may qualify if:

• \. Able to read, understand and voluntarily provide written informed consent. 2. Healthy male or female, ≥ 18 years of age seeking treatment for unwanted fat in the flanks.
• \. BMI score is less than 35. 4. Agree to not making any major changes in their diet or lifestyle during the course of the study.
• \. Able and willing to comply with the treatment/follow-up schedule and requirements.
• \. Women of child-bearing age are required to be using a reliable method of birth control at least 3 months prior to study enrollment and for the duration of the study, and have a negative Urine Pregnancy test at baseline.

You may not qualify if:

• \. Pregnant in the last 3 months, intending to become pregnant, postpartum or nursing in the last 6 months.
• \. Any previous liposuction/lipo-sculpture or any type of surgical procedure in the treatment area in the past 12 months.
• \. History of immunosuppression/immune deficiency disorders (including AIDS and HIV infection) or use of immunosuppressive medications, 6 months prior to and during the course of the study.
• \. History of hyperlipidemia, diabetes mellitus, hepatitis, blood coagulopathy or excessive bleeding.
• \. Use of antiplatelet medications (81 mg acetylsalicylic acid daily permitted), anticoagulants, thrombolytics or anti-inflammatory medications within 2 weeks of treatment.
• \. 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.
• \. Having a permanent implant in the treatment area such as metal plates or an injected chemical substance such as silicone or parenteral gold therapy (gold sodium thiomalate).
• \. Use of medications, herbs, food supplements, and vitamins known to induce photosensitivity to light exposure at the wavelength used or history of photosensitivity disorder.
• \. Suffering from significant skin conditions in the treatment area or inflammatory skin conditions including but not limited to open lacerations, abrasions, herpes sores, cold sores, active infections.
• \. Tattoos in the treatment area. 11. Poor skin quality (severe laxity). 12. Abdominal wall, muscular abnormality or hernia on physical examination. 13. Use of retinoids such as oral isotretinoin (Accutane™) within the past six months or during course of the study.
• \. History of keloid or hypertrophic scar formation or poor wound healing in the treatment area.
• \. As per the investigator's discretion, any physical or mental condition which may make it unsafe for the subject to participate.
• \. Unable or unlikely to refrain from sun exposure, artificial tanning, including the use of tanning booths, prior to (six weeks) and during the course of the evaluation.

Sponsors & Collaborators

• Venus Concept: lead

Study Sites (5)

Berman Skin Institute

Los Altos, California, 94022, United States

Location

Laser & Skin Surgery Medical Group, Inc

Sacramento, California, 95816, United States

Location

Batra Dermatology

Santa Monica, California, 90404, United States

Location

aFresh Medispa

Chicago, Illinois, 60026, United States

Location

UT Southwestern Medical Center Department of Plastic Surgery

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

Platelet Glycoprotein IV Deficiency

Results Point of Contact

• Title: Director of Clinical Affairs
• Organization: Venus Concept

mgronski@venusconcept.com

1-888-907-0115

Study Officials

• Yoni Iger, PhD

  Venus Concept LTD

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Up to 200 subjects will be enrolled in the study to receive 3 Diode and 3 RF treatments.

Study Record Dates

• First Submitted: July 4, 2019
• First Posted: July 9, 2019
• Study Start: September 19, 2019
• Primary Completion: October 22, 2022
• Study Completion: October 22, 2022
• Last Updated: April 23, 2024
• Results First Posted: April 23, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)