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Effects of Red Light LED Therapy on Body Contouring

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ClinicalTrials.gov Identifier: NCT03242564
Recruitment Status : Completed
First Posted : August 8, 2017
Last Update Posted : August 8, 2017
Sponsor:
Information provided by (Responsible Party):
Vevazz, LLC

Study Description
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Brief Summary:
The purpose of this study is to determine whether red light therapy using LED 650nm red light for body contouring of the waist, hips and thighs is as effective as red light therapy using Laser 635nm red light.

Condition or disease Intervention/treatment Phase
Obesity Device: Vevazz LED Not Applicable

Detailed Description:

Red light laser therapy using 635nm red light laser technology has previously been shown to cause lipolysis in subcutaneous fat as a non-surgical method to promote weight loss and body contouring. This study hypothesizes that red LED light therapy using 650nm red light LED (light emitting diode) technology produces similar results to the laser device (red LASER 635nm) when preformed using a specified treatment protocol.

Furthermore, it is hypothesized that the Vevazz therapy program achieves the results after a single 28 minute treatment. The predicate 635nm LED device (Photonica Professional by Ward Photonics) achieves its results after one 32 minute therapy program.

The Vevazz therapy program uses the Vevazz LED device for fat removal using LED red light therapy. This multi-site study reviews results from 66 randomly selected patients after a single treatment using the Vevazz LED device.


Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 66 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Retrospective Analysis of the Effects of Red Light LED Therapy on Body Contouring
Actual Study Start Date : July 10, 2017
Actual Primary Completion Date : July 21, 2017
Actual Study Completion Date : July 21, 2017
Arms and Interventions
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Arm Intervention/treatment
Experimental: Active Device

Active Device: Vevazz LED red light therapy system

Vevazz LED red light therapy system is a treatment regimen using the Vevazz LED device for fat removal using LED red light therapy.

 Device: Vevazz LED
Vevazz LED red light therapy is a non-invasive dermatological aesthetic treatment for the reduction of circumference of hips, waist and thighs.


Outcome Measures
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Primary Outcome Measures :
  1. Change in Fat Amount (Reduction) in Treatment Area as Measured in Inches Lost [ Time Frame: One 28 minute treatment session. ]
    Circumferential measurement of thighs, hips and waist before and after treatment.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 77 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • At least 18 years or older.
  • May be male or female.
  • Generally good health.

Exclusion Criteria:

  • Minors.
  • Open wounds or sores.
  • Pacemaker.
  • Photosensitivity.
  • Epilepsy.
  • Any form of cancer.
  • Severe kidney or liver problems.
  • Thyroid problems.
  • Pregnant or nursing.
Contacts and Locations
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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): NCT03242564


Locations
United States, Texas
Vevazz, LLC
Dallas, Texas, United States, 75204
Sponsors and Collaborators
Vevazz, LLC
Investigators
Study Director: Jamie Fettig Owner
More Information
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Responsible Party: Vevazz, LLC
ClinicalTrials.gov Identifier: NCT03242564     History of Changes
Other Study ID Numbers: Vev-2017-1
First Posted: August 8, 2017    Key Record Dates
Last Update Posted: August 8, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No current plan to share data.

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
Product Manufactured in and Exported from the U.S.: Yes