Clinical Evaluation of the Safety and Efficacy of a 1060 nm Diode Laser (Flanks)

Venus Concept

Status

Completed

Conditions

Fat Atrophy

Treatments

Device: 1060nm Diode laser

Study type

Interventional

Funder types

Industry

Identifiers

NCT03756168

CS0518

Details and patient eligibility

About

The objective of this clinical study is to assess the safety and efficacy of using a 1060 nm diode laser for non-invasive fat reduction of the flanks.

Full description

Open-label, baseline-controlled, evaluator-blind, multi-center study evaluating a 1060 nm diode laser for non-invasive fat reduction of the flanks. The study will enroll up to 50 subjects requesting non-invasive lipolysis of the flanks. Each subject will receive a single study treatment. Subjects will be followed at six weeks and twelve weeks post-treatment. Twelve week outcome will be compared to baseline.

Enrollment

30 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

able to read, understand and voluntarily provide written informed consent
healthy male or female > 18 years of age seeking treatment for unwanted fat in the abdomen
BMI score is less then 30
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 enrolment and for the duration of the study, have a negative urine pregnancy test baseline

Exclusion criteria

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 month prior to and during the course of the study
History of hyperlipidemia, diabetes, hepatitis, blood coagulopathy or excessive bleeding
Use of antiplatelet medications (81 mg of acetylsalicylic acid daily is permitted), anticoagulants, thrombocytes or any-inflammatory medications within 2 weeks of treatment
Having a history of skin cancer or any other cancer in the area to be treated, including presence of malignant or pre-malignant pigmented lesions
Having a permanent implant in the treatment area such as a metal plate or injected chemical substance such as silicone pr parenteral gold therapy (gold sodium thiomalate)
Use of medications, herbs or food supplements and vitamins known to induce photosensitivity to light exposure at the wavelength used 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
Poor quality skin (laxity)
Abdominal wall, muscular abnormality or hernia on physical examination
Unstable weight within the last 6 months (+ or - 3% weight change in the prior six months)
Participation in another clinical study involving the same anatomical areas within the last 6 months
History of keloid and hypertrophic scar formation or poor wound healing in the treatment area
As per the investigators discretion any physician or mental condition which may make it unsafe for the subject to participate