An interventional study of Ward Photonics Photonica Professional in Obesity, sponsored by Ward Photonics LLC. Completed. Open to participants aged 18 Years to 74 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-06-23.
Sponsored by Ward Photonics LLC · Not applicable, Interventional, and Treatment
The purpose of this study is to determine whether red light therapy using LED 635nm red light for body contouring of the waist, hips and thighs is as effective as red light therapy using Laser 635nm red light.
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 635nm red light LED (light emitting diode) technology produces similar results to the laser device (red LASER 635nm) when performed using a specified treatment protocol.
Furthermore, it is hypothesized that the UltraSlim Cold Light therapy program achieves the results after a single 32-minute treatment. The predicate 635nm laser device (Zerona by Erchonia) achieves its results after six treatments combined with a diet and exercise regimen.
UltraSlim Cold Light® is a patented process using the Photonica Professional device for fat removal using LED red light therapy. This multi-site study reviews results from 58 randomly selected patients after a single treatment using the Photonica Professional device (i.e. UltraSlim Cold Light®).
Ward Photonics LLC is the lead sponsor of 5 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Active Device: Ward Photonics Photonica Professional Red light therapy system Intervention: Device: Ward Photonics Photonica Professional
Device: 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.
Fat Reduction in Treatment Zone as Measured in Inches Lost
Circumferential measurement of thighs, hips and waist before and after treatment.
Time frame: Single 32-minute treatment session
| Milestone | Active Device |
|---|---|
| Started | 58 |
| Completed | 58 |
| Not completed | 0 |
Circumferential measurement of thighs, hips and waist before and after treatment.
| inch | Active Device |
|---|---|
| Fat Reduction in Treatment Zone as Measured in Inches Lost | 3.5 (1.625 to 10) |
Collected over 6 MONTHS. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Active Device | — | 0/58 (0%) | 0/58 (0%) |
| Age, Categorical(Participants) | Active Device |
|---|---|
| <=18 years | 1 |
| Between 18 and 65 years | 54 |
| >=65 years | 3 |
| Age, Continuous(Years) | Active Device |
|---|---|
| Mean | 43.3 (18 to 74) |
| Sex: Female, Male(Participants) | Active Device |
|---|---|
| Female | 46 |
| Male | 12 |
| Region of Enrollment(participants) | Active Device |
|---|---|
| United States | 58 |
No study locations are listed for this record.
Plan to share: No — No current plan to share data.
No publications or documents are linked to this record.
This study is completed, as verified in Jun 2017. You cannot join it, but the record below documents what was studied.
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