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Subject Evaluation of a 1064nm Diode Laser/RF

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ClinicalTrials.gov Identifier: NCT04090853
Recruitment Status : Not yet recruiting
First Posted : September 16, 2019
Last Update Posted : October 2, 2019
Sponsor:
Information provided by (Responsible Party):
Venus Concept

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Subcutaneous Fat Disorder Device: Venus Bliss Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Single group assessed patient feedback regarding satisfaction post treatment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Estimated Study Start Date : October 1, 2019
Estimated Primary Completion Date : October 1, 2020
Estimated Study Completion Date : October 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Device: Venus Bliss
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.




Primary Outcome Measures :
  1. Patient Overall Satisfaction [ Time Frame: Week 26 ]
    Patients rate their satisfaction with treatment outcomes at the final follow up visit using a patient survey by answering 12 questions

  2. Patient Treatment Satisfaction [ Time Frame: Week 26 ]
    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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Able to read, understand and voluntarily provide written informed consent.
  2. Healthy male or female, ≥ 18 years of age seeking treatment for unwanted fat in the flanks and or abdomen
  3. BMI score is less than 35.
  4. Able and willing to comply with the treatment/follow-up schedule and requirements.
  5. 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:

  1. Pregnant, intending to become pregnant, postpartum or nursing in the last 6 months.
  2. Any previous liposuction/lipo-sculpture or any type of surgical procedure in the treatment area in the past 12 months.
  3. 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.
  4. History of hyperlipidemia, diabetes mellitus, hepatitis, blood coagulopathy or excessive bleeding.
  5. Use of antiplatelet medications (81 mg acetylsalicylic acid daily permitted), anticoagulants, thrombolytics or anti-inflammatory medications within 2 weeks of treatment.
  6. 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.
  7. 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).
  8. Use of medications, herbs, food supplements, and vitamins known to induce photosensitivity to light exposure at the wavelength used or history of photosensitivity disorder.
  9. 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.
  10. Tattoos in the treatment area.
  11. Poor skin quality (severe laxity).
  12. Abdominal wall, muscular abnormality or hernia on physical examination.
  13. Use of retinoids such as oral isotretinoin (Accutane™) within the past six months or during course of the study.
  14. History of keloid or hypertrophic scar formation or poor wound healing in the treatment area.
  15. As per the investigator's discretion, any physical or mental condition which may make it unsafe for the subject to participate.
  16. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04090853


Contacts
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Contact: Tracey L Mancuso 416-907-0115 tracey@venusconcept.com
Contact: Louie Cabigao 416-907-0115 lcabigao@venusconcept.com

Locations
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United States, Colorado
Shah Aesthetic Surgery Not yet recruiting
Denver, Colorado, United States, 80206
Contact: Manish Shah, MD    303-708-8234    info@drmanishshah.com   
United States, Massachusetts
Medical Management Solutions INC Not yet recruiting
Foxboro, Massachusetts, United States, 02035
Contact: Howard Kesselman, MD    508-427-3890    howard.kesselman@steward.org   
United States, New York
SRS Dermatology Not yet recruiting
Woodmere, New York, United States, 11598
Contact: Suzanne Rozenberg, MD    516-318-6595    Docsq16@gmail.com   
Sponsors and Collaborators
Venus Concept
Investigators
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Study Director: Yoni Iger Venus Concept LTD

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Responsible Party: Venus Concept
ClinicalTrials.gov Identifier: NCT04090853     History of Changes
Other Study ID Numbers: BL1119
First Posted: September 16, 2019    Key Record Dates
Last Update Posted: October 2, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Lipid Metabolism Disorders
Metabolic Diseases