Status:
COMPLETED
Clinical Evaluation of the Safety and Efficacy of a 1060nm Diode Laser (Abdomen)
Lead Sponsor:
Venus Concept
Conditions:
Fat Atrophy
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 wi...
Detailed Description
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 no...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 14 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 2 2019
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT03756350
Start Date
November 14 2018
End Date
July 2 2019
Last Update
July 3 2023
Active Locations (2)
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1
Laser and Skin Surgery Center of Northern California
Sacramento, California, United States, 95816
2
Southwestern Medical Center Department of Plastic Surgery
Dallas, Texas, United States, 75390