Subject Evaluation of a 1064nm Diode Laser/RF

Not Applicable

Withdrawn

• Conditions: Subcutaneous Fat Disorder
• Interventions: Device: Venus Bliss

• Registration Number: NCT04090853
• Lead Sponsor: Venus Concept

Brief Summary

Open-label, baseline-controlled, multi-center study evaluating a 1064 nm diode laser, pulsed electromagnetic fields and vacuum assisted radio frequency for non-invasive fat reduction of the abdomen and flanks.

Detailed Description

The study will enroll up to 200 subjects requesting non-invasive lipolysis of the abdomen and flanks. Each subject will receive up to 3 study treatments of the diode laser and up to 3 treatments of the pulsed electromagnetic fields and vacuum assisted radio frequency study treatments. Subjects will be followed at 24 weeks post diode treatments to observe their satisfaction with treatment outcomes.

Study Timeline

• Study First Submitted: 2019-09-12
• Study First Submitted QC: 2019-09-13
• Study First Posted: 2019-09-16
• Study Start: 2019-10-01
• Primary Completion: 2020-07-08
• Study Completion: 2020-07-08
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-05
• Last Update Posted: 2023-05-08

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. 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 and or abdomen
3. BMI score is less than 35.
4. Able and willing to comply with the treatment/follow-up schedule and requirements.
5. 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.

Exclusion Criteria

1. Pregnant, intending to become pregnant, postpartum or nursing in the last 6 months.
2. Any previous liposuction/lipo-sculpture or any type of surgical procedure in the treatment area in the past 12 months.
3. 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.
4. History of hyperlipidemia, diabetes mellitus, hepatitis, blood coagulopathy or excessive bleeding.
5. Use of antiplatelet medications (81 mg acetylsalicylic acid daily permitted), anticoagulants, thrombolytics or anti-inflammatory medications within 2 weeks of treatment.
6. 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.
7. 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).
8. Use of medications, herbs, food supplements, and vitamins known to induce photosensitivity to light exposure at the wavelength used or history of photosensitivity disorder.
9. 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.
10. 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.
14. History of keloid or hypertrophic scar formation or poor wound healing in the treatment area.
15. As per the investigator's discretion, any physical or mental condition which may make it unsafe for the subject to participate.
16. 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patient Treatment Group	Venus Bliss	Up to three Diode and Radio Frequency treatments and up to three additional radio frequency treatments will be performed per patient at the discretion of the principal investigator. Diode treatments will be spaced six weeks apart while the radio frequency treatments will be spaced between 2-3 weeks apart.

Primary Outcome Measures

Name	Time	Method
Patient Overall Satisfaction	Week 26	Patients rate their satisfaction with treatment outcomes at the final follow up visit using a patient survey by answering 12 questions
Patient Treatment Satisfaction	Week 26	Patients rate their treatment satisfaction using a 5 point Likert Scale. The Likert scale ranges from 1 = very unsatisfied 2 = unsatisfied 3 = neutral 4 = satisfied 5 = very satisfied

Trial Locations

Locations (3)

Shah Aesthetic Surgery; 🇺🇸 Denver, Colorado, United States

SRS Dermatology; 🇺🇸 Woodmere, New York, United States

Medical Management Solutions INC; 🇺🇸 Foxboro, Massachusetts, United States