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The objective of this clinical study is to assess the safety and efficacy of using a 1060 nm diode laser for non-invasive fat reduction of the flanks.
Open-label, baseline-controlled, evaluator-blind, multi-center study evaluating a 1060 nm diode laser for non-invasive fat reduction of the flanks. The study will enroll up to 50 subjects requesting non-invasive lipolysis of the flanks. Each subject will receive a single study treatment. Subjects will be followed at six weeks and twelve weeks post-treatment. Twelve week outcome will be compared to baseline.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All subjects | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 1060nm Diode laser | Device | All subjects received a single treatment with Venus Bliss' 1064 nm laser administered to the flanks Venus Bliss is a non-invasive medical aesthetic device designed for body contouring. The device contains four 1060 nm diode laser applicators which are 60x60 mm in size. It has a separate RF/PEMF applicator, but this was not used in this study. There is a belt included with the system to allow for the secure attachment of the applicators to the treatment area. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the Percentage of Fat Thickness From Baseline to 12-weeks Post-treatment | Change in the percentage of fat thickness of the adipose layer as measured by ultrasound at 12 weeks post-treatment as compared to baseline. | Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Abdominal Circumference From Baseline to 12 Weeks Post-treatment | Change in the abdominal circumference at 12 weeks post-treatment as compared to baseline | Week 12 |
| Subject Satisfaction |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Suzanne Kilmer, MD | Skin and Laser Centre of Northern California | Principal Investigator |
| Jeffery Kenkel, MD | UT Southwestern | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Laser and Skin Surgery Center of Northern California | Sacramento | California | 95816 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37608607 | Result | Kang A, Kislevitz M, Wamsley C, Barillas J, Hoopman J, Kenkel J, Kilmer S. Clinical evaluation of the safety and efficacy of a 1060 nm diode laser for non-invasive fat reduction of the flanks. J Cosmet Dermatol. 2023 Nov;22(11):3017-3025. doi: 10.1111/jocd.15954. Epub 2023 Aug 22. |
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| ID | Title | Description |
|---|---|---|
| FG000 | All Subjects | All subjects received a single treatment with Venus Bliss' 1064 nm laser administered to the flanks Venus Bliss is a non-invasive medical aesthetic device designed for body contouring. The device contains four 1060 nm diode laser applicators which are 60x60 mm in size. It has a separate RF/PEMF applicator, but this was not used in this study. There is a belt included with the system to allow for the secure attachment of the applicators to the treatment area. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | All Subjects Treated | All subjects received a single treatment with Venus Bliss' 1064 nm laser administered to the flanks Venus Bliss is a non-invasive medical aesthetic device designed for body contouring. The device contains four 1060 nm diode laser applicators which are 60x60 mm in size. It has a separate RF/PEMF applicator, but this was not used in this study. There is a belt included with the system to allow for the secure attachment of the applicators to the treatment area. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in the Percentage of Fat Thickness From Baseline to 12-weeks Post-treatment | Change in the percentage of fat thickness of the adipose layer as measured by ultrasound at 12 weeks post-treatment as compared to baseline. | Posted | Mean | Standard Error | percentage of body fat | Week 12 |
|
12 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | All Subjects | All subjects received a single treatment with Venus Bliss' 1064 nm laser administered to the flanks Venus Bliss is a non-invasive medical aesthetic device designed for body contouring. The device contains four 1060 nm diode laser applicators which are 60x60 mm in size. It has a separate RF/PEMF applicator, but this was not used in this study. There is a belt included with the system to allow for the secure attachment of the applicators to the treatment area. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Affairs | Venus Concept | 888-907-0115 | mgronski@venusconcept.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 5, 2018 | Aug 8, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D054023 | Lasers, Semiconductor |
| ID | Term |
|---|---|
| D007834 | Lasers |
| D055096 | Optical Devices |
| D004864 | Equipment and Supplies |
| D055618 | Radiation Equipment and Supplies |
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|
Subject satisfaction with treatment at 12 weeks was assessed using the 5-point Likert subject satisfaction scale. 5 is very satisfied, while 1 is very unsatisfied
| Week 12 |
| Treatment Pain | Treatment pain assessed immediately post-treatment as measured using the Wong-Baker Faces Scale. Pain was measured on a scale from 0-10 (10 worst pain ever, to 0 no pain at all) | Day 1 |
| UT Southwestern Medical Centre |
| Dallas |
| Texas |
| 75390 |
| United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Fitzpatrick Skin Type | Fitzpatrick Skin Type criteria I: Always burns, never tans Pale/ivory skin, Blue eyes, blond/red hair Mod. to severe freckles II: Usually burns, min tanning Fair skin, Blue/green/hazel eyes, blonde/red hair Light to moderate freckles III: Mild burns, uniform tanning Creamy white/fair skin, hazel/light brown eyes Dark blonde to light brown hair Min freckling IV: Burns minimally, tans well Light brown/olive skin, Brown eyes&hair V: Very rarely burns, tans easily/rapidly Dark brown/black skin, eyes&hair VI: Never tans or burns Black skin&hair Brown/black eyes | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Change in Abdominal Circumference From Baseline to 12 Weeks Post-treatment | Change in the abdominal circumference at 12 weeks post-treatment as compared to baseline | Posted | Mean | Standard Error | centimeters | Week 12 |
|
|
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| Secondary | Subject Satisfaction | Subject satisfaction with treatment at 12 weeks was assessed using the 5-point Likert subject satisfaction scale. 5 is very satisfied, while 1 is very unsatisfied | Posted | Mean | Standard Deviation | units on a scale | Week 12 |
|
|
|
| Secondary | Treatment Pain | Treatment pain assessed immediately post-treatment as measured using the Wong-Baker Faces Scale. Pain was measured on a scale from 0-10 (10 worst pain ever, to 0 no pain at all) | Posted | Mean | Standard Deviation | score on a scale | Day 1 |
|
|
|
| 0 |
| 30 |
| 0 |
| 30 |
| 0 |
| 30 |
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