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4.2 C
New York

Subject Evaluation of a 1064nm Diode Laser/RF

0

Studies

Study First Submitted Date 2019-09-12
Study First Posted Date 2019-09-16
Last Update Posted Date 2023-05-08
Start Month Year October 1, 2019
Primary Completion Month Year July 8, 2020
Verification Month Year May 2023
Verification Date 2023-05-31
Last Update Posted Date 2023-05-08

Detailed Descriptions

Sequence: 20718703
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.

Facilities

Sequence: 200074861 Sequence: 200074862 Sequence: 200074863
Name Shah Aesthetic Surgery Name Medical Management Solutions INC Name SRS Dermatology
City Denver City Foxboro City Woodmere
State Colorado State Massachusetts State New York
Zip 80206 Zip 02035 Zip 11598
Country United States Country United States Country United States

Conditions

Sequence: 52162781
Name Subcutaneous Fat Disorder
Downcase Name subcutaneous fat disorder

Id Information

Sequence: 40152796
Id Source org_study_id
Id Value BL1119

Countries

Sequence: 42562259
Name United States
Removed False

Design Groups

Sequence: 55584887
Group Type Other
Title Patient Treatment Group
Description 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.

Interventions

Sequence: 52478027
Intervention Type Device
Name Venus Bliss
Description 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.

Design Outcomes

Sequence: 177350605 Sequence: 177350606
Outcome Type primary Outcome Type primary
Measure Patient Overall Satisfaction Measure Patient Treatment Satisfaction
Time Frame Week 26 Time Frame Week 26
Description Patients rate their satisfaction with treatment outcomes at the final follow up visit using a patient survey by answering 12 questions Description 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

Browse Conditions

Sequence: 193456200 Sequence: 193456201
Mesh Term Lipid Metabolism Disorders Mesh Term Metabolic Diseases
Downcase Mesh Term lipid metabolism disorders Downcase Mesh Term metabolic diseases
Mesh Type mesh-list Mesh Type mesh-ancestor

Sponsors

Sequence: 48311936
Agency Class INDUSTRY
Lead Or Collaborator lead
Name Venus Concept

Overall Officials

Sequence: 29281271
Role Study Director
Name Yoni Iger
Affiliation Venus Concept LTD

Design Group Interventions

Sequence: 68139118
Design Group Id 55584887
Intervention Id 52478027

Eligibilities

Sequence: 30760974
Gender All
Minimum Age 18 Years
Maximum Age N/A
Healthy Volunteers Accepts Healthy Volunteers
Criteria 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.

Adult True
Child False
Older Adult True

Calculated Values

Sequence: 254304651
Number Of Facilities 3
Registered In Calendar Year 2019
Actual Duration 9
Were Results Reported False
Has Us Facility True
Has Single Facility False
Minimum Age Num 18
Minimum Age Unit Years
Number Of Primary Outcomes To Measure 2

Designs

Sequence: 30507174
Allocation N/A
Intervention Model Single Group Assignment
Observational Model
Primary Purpose Treatment
Time Perspective
Masking None (Open Label)
Intervention Model Description Single group assessed patient feedback regarding satisfaction post treatment

Responsible Parties

Sequence: 28873455
Responsible Party Type Sponsor