Effects of Red Light LED Therapy on Body Contouring
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ClinicalTrials.gov Identifier: NCT03470272 |
Recruitment Status : Unknown
Verified August 2018 by Manamed Inc..
Recruitment status was: Not yet recruiting
First Posted : March 19, 2018
Last Update Posted : August 17, 2018
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Tracking Information | |||||||
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First Submitted Date ICMJE | December 14, 2017 | ||||||
First Posted Date ICMJE | March 19, 2018 | ||||||
Last Update Posted Date | August 17, 2018 | ||||||
Estimated Study Start Date ICMJE | September 30, 2018 | ||||||
Estimated Primary Completion Date | November 30, 2018 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
Change in Fat Amount (Reduction) in Treatment Area as Measured in Inches Lost [ Time Frame: One 28 minute session ] Circumferential measurement of thighs, hips and waist before and after treatment.
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Original Primary Outcome Measures ICMJE | Same as current | ||||||
Change History | |||||||
Current Secondary Outcome Measures ICMJE | Not Provided | ||||||
Original Secondary Outcome Measures ICMJE | Not Provided | ||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title ICMJE | Effects of Red Light LED Therapy on Body Contouring | ||||||
Official Title ICMJE | Effects of Red Light LED Therapy on Body Contouring | ||||||
Brief Summary | 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. | ||||||
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 one 28 minute treatment period. The predicate 635nm LED device (Photonica Professional by Ward Photonics) achieves its results after one 32 minute therapy program. The FB Professional therapy program uses the FB Professional LED device for fat removal using LED red light therapy. This multi-site study reviews results from 70 randomly selected patients after a single treatment using the FB Professional LED device. |
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Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Not Applicable | ||||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Obesity | ||||||
Intervention ICMJE |
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Study Arms ICMJE | Experimental: Active Device
Active Device: The FB Professional LED red light therapy system FB Professional is a treatment regime using the FB Professional device for fat removal using red light therapy. Intervention device: FB Professional LED red light therapy is a non-invasive dermatological aesthetic treatment for the reduction of circumference of hips, waist and thighs. Interventions:
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Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status ICMJE | Unknown status | ||||||
Estimated Enrollment ICMJE |
66 | ||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||
Estimated Study Completion Date ICMJE | November 30, 2018 | ||||||
Estimated Primary Completion Date | November 30, 2018 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 77 Years (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers ICMJE | Yes | ||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries ICMJE | United States | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT03470272 | ||||||
Other Study ID Numbers ICMJE | Manamed | ||||||
Has Data Monitoring Committee | No | ||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||||
Current Responsible Party | Manamed Inc. | ||||||
Original Responsible Party | Same as current | ||||||
Current Study Sponsor ICMJE | Manamed Inc. | ||||||
Original Study Sponsor ICMJE | Same as current | ||||||
Collaborators ICMJE | Not Provided | ||||||
Investigators ICMJE |
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PRS Account | Manamed Inc. | ||||||
Verification Date | August 2018 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |