- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04090853
Subject Evaluation of a 1064nm Diode Laser/RF
May 5, 2023 updated by: Venus Concept
Subject Evaluation of the Efficacy of a 1064 nm Diode Laser, Pulsed Electro-Magnetic Fields and Vacuum Assisted Multipolar Radio Frequency for Non-invasive Contouring of the Abdomen and Flanks
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.
Study Overview
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 Type
Interventional
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Colorado
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Denver, Colorado, United States, 80206
- Shah Aesthetic Surgery
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Massachusetts
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Foxboro, Massachusetts, United States, 02035
- Medical Management Solutions INC
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New York
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Woodmere, New York, United States, 11598
- SRS Dermatology
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
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 flanks and or abdomen
- BMI score is less than 35.
- 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.
Exclusion Criteria:
- Pregnant, 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.
- Poor skin quality (severe laxity).
- Abdominal wall, muscular abnormality or hernia on physical examination.
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Patient Treatment Group
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.
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The investigational device (Venus Bliss™) is a non-invasive medical aesthetic device designed for body contouring.
The device is comprised of a console, four 1064 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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patient Overall Satisfaction
Time Frame: Week 26
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Patients rate their satisfaction with treatment outcomes at the final follow up visit using a patient survey by answering 12 questions
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Week 26
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Patient Treatment Satisfaction
Time Frame: Week 26
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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
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Week 26
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Yoni Iger, Venus Concept LTD
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2019
Primary Completion (Actual)
July 8, 2020
Study Completion (Actual)
July 8, 2020
Study Registration Dates
First Submitted
September 12, 2019
First Submitted That Met QC Criteria
September 13, 2019
First Posted (Actual)
September 16, 2019
Study Record Updates
Last Update Posted (Actual)
May 8, 2023
Last Update Submitted That Met QC Criteria
May 5, 2023
Last Verified
May 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BL1119
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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