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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-14

Study Completion Date

2019-07-02

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study is evaluating a 1060nm diode laser for non-invasive fat reduction of the abdomen. The study will enrolled up to 50 subjects requesting non-invasive lipolysis of the abdomen. Each subject will receive a single study treatment. Subjects will be followed at six and twelve weeks post treatment. Twelve week outcomes will be compared to baseline.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Subject Evaluation of a 1064nm Diode Laser/RF

NCT04090853

Subcutaneous Fat Disorder

WITHDRAWN NA

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

NCT04012814

Adipose Tissue Atrophy

COMPLETED NA

LED Device for Non-Invasive Lipolysis

NCT03171051

Lipolysis

TERMINATED NA

Analysis of the Performance of 1060 nm Diode and Radio Frequency Prior to Abdominoplasty

NCT04616898

Adipose Tissue Atrophy

COMPLETED NA

SlimShape Device for Abdominal Fat and Circumference Reduction

NCT02999763

Fat Disorder

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Open-label baseline controlled evaluator-blind multi-centre study evaluating a 1060nm diode laser for non-invasive fat reduction of the abdomen. The study will enrolled up to 50 subjects requesting non-invasive lipolysis of the abdomen. Each subject will receive a single study treatment which takes approximately 25 minutes. Subjects will be followed at six and twelve weeks post treatment. Twelve week outcomes will be compared to baseline.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Fat Atrophy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Blinded reviewer will evaluate the pre and post photos

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Treatment subjects

Single group of subjects which will have the treatment of a 1060nm diode laser administered to them.

Group Type EXPERIMENTAL

1060nm diode laser

Intervention Type DEVICE

Non-invasive medical aesthetic device designed for body contouring. The device is comprised of a console, four 1060nm diode laser applicators which are 60x60 mm in size. There is a belt included with the system to allow for the secure application of the applicators to the treatment area.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

1060nm diode laser

Non-invasive medical aesthetic device designed for body contouring. The device is comprised of a console, four 1060nm diode laser applicators which are 60x60 mm in size. There is a belt included with the system to allow for the secure application of the applicators to the treatment area.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes