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A Retrospective Analysis of the Effects of Red Light Therapy on Body Contouring

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02867150
First Posted: August 15, 2016
Last Update Posted: June 23, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Ward Photonics LLC
Results First Submitted: August 18, 2016  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Obesity
Intervention: Device: Ward Photonics Photonica Professional

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Active Device

Active Device: Ward Photonics Photonica Professional Red light therapy system Intervention: Device: Ward Photonics Photonica Professional

Ward Photonics Photonica Professional: Active Device: Ward Photonics, Photonica Professional Red light therapy system

UltraSlim Cold Light® is the name of a patented treatment regimen using the Photonica Professional device for fat removal using LED red light therapy.


Participant Flow:   Overall Study
    Active Device
STARTED   58 
COMPLETED   58 
NOT COMPLETED   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Active Device

Active Device: Ward Photonics Photonica Professional Red light therapy system Intervention: Device: Ward Photonics Photonica Professional

Ward Photonics Photonica Professional: Active Device: Ward Photonics, Photonica Professional Red light therapy system

UltraSlim Cold Light® is the name of a patented treatment regimen using the Photonica Professional device for fat removal using LED red light therapy.


Baseline Measures
   Active Device 
Overall Participants Analyzed 
[Units: Participants]
 58 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      1   1.7% 
Between 18 and 65 years      54  93.1% 
>=65 years      3   5.2% 
Age 
[Units: Years]
Mean (Full Range)
 43.3 
 (18 to 74) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      46  79.3% 
Male      12  20.7% 
Region of Enrollment [1] 
[Units: Participants]
 
United States   58 
[1] Multi-site U.S. Study


  Outcome Measures

1.  Primary:   Fat Reduction in Treatment Zone as Measured in Inches Lost   [ Time Frame: Single 32-minute treatment session ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Ellyn Levine M.D.
Organization: Optimal Health and Weight Center
phone: (619) 567-6914
e-mail: dr.levine@teamtsfl.com



Responsible Party: Ward Photonics LLC
ClinicalTrials.gov Identifier: NCT02867150     History of Changes
Other Study ID Numbers: MLS-1510
First Submitted: January 3, 2016
First Posted: August 15, 2016
Results First Submitted: August 18, 2016
Results First Posted: June 23, 2017
Last Update Posted: June 23, 2017