Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to assess the safety and efficacy of treatment with the Liposonix System (Model 2) for the circumferential reduction of subcutaneous adipose tissue (SAT) of the thighs.
Subjects received a single treatment (Liposonix System) on one randomly assigned thigh. The opposite thigh was not treated and served as a control for each subject.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treated Thigh | Experimental | Subjects randomly received treatment of either the left or right thigh with the Liposonix System (Model 2) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Liposonix System (Model 2) | Device | Treatment of Subcutaneous Adipose Tissue in the thighs using High Intensity Focused Ultrasound |
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Improvement in Thigh Circumference | Clinical improvement measured by change from baseline thigh circumference after treatment | 12 weeks (minus baseline) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Showing Clinical Improvement Using the Global Aesthetic Improvement Scale (GAIS) Post Treatment, Assessed by Investigator | Investigator improvement at 12 weeks using the GAIS Scale, as presented based on percentage of subjects showing improvement. Outcome presented in % of participants that had GAIS scores of either 4 (improved) or 5 (much improved) at 12 weeks post treatment. *GAIS Scale: 1=Much Worse, 2=Worse, 3=No Improvement, 4=Improved, 5=Much Improved |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Van Dyke Laser and Skin | Paradise Valley | Arizona | 85253 | United States | ||
| Solta Medical Aesthetic Center |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Treated Thigh | Randomly chosen left or right thigh treated with the Liposonix System (Model 2) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Intent to Treat Cohort
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Treated Thigh | Subjects randomly received treatment of either the left or right thigh with the Liposonix System (Model 2) |
| 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 | Clinical Improvement in Thigh Circumference | Clinical improvement measured by change from baseline thigh circumference after treatment | Per Protocol | Posted | Least Squares Mean | Standard Error | centimeter | 12 weeks (minus baseline) |
|
Adverse events were collected from day 0 through study exit (12-weeks post treatment)
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treated Thigh | Randomly chosen left or right thigh treated with the Liposonix System (Model 2) |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ecchymosis | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Programs | Solta Medical | 510-259-5284 | aloncaric@solta.com |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 12 weeks |
| Patient Satisfaction Using 1-5 Likert Scale | Likert scale ranges from 1=Very Dissatisfied to 4=satisfied, 5=very satisfied. Percentage of participants rated 4 and 5 are reported below | 12 weeks |
| Safety Assessment | Discomfort level during treatment using the Visual Analog Scale (VAS) and post-treatment skin reponses or side effects using a 0-3 severity scale. | 1, 4, 8, 12 weeks |
| Subcutaneous Adipose Thickness | Ultrasound assisted measurement of adipose tissue thickness | 12 weeks |
| Global Aesthetic Improvement Scale (GAIS) Score Post Treatment Assessed by Investigator for Determining Clinical Improvement | Mean Investigator improvement at 12 weeks using the GAIS Scale. *GAIS Scale: 1=Much Worse, 2=Worse, 3=No Improvement, 4=Improved, 5=Much Improved | 12 weeks |
| Hayward |
| California |
| 94545 |
| United States |
| Jewell Plastic Surgery Center | Eugene | Oregon | 97401 | United States |
| Solish M.D. | Toronto | Ontario | Canada |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|
| Participants |
|
|
| Secondary | Percentage of Participants Showing Clinical Improvement Using the Global Aesthetic Improvement Scale (GAIS) Post Treatment, Assessed by Investigator | Investigator improvement at 12 weeks using the GAIS Scale, as presented based on percentage of subjects showing improvement. Outcome presented in % of participants that had GAIS scores of either 4 (improved) or 5 (much improved) at 12 weeks post treatment. *GAIS Scale: 1=Much Worse, 2=Worse, 3=No Improvement, 4=Improved, 5=Much Improved | Per protocol | Posted | Number | Percentage of subjects improved | 12 weeks |
|
|
|
| Secondary | Patient Satisfaction Using 1-5 Likert Scale | Likert scale ranges from 1=Very Dissatisfied to 4=satisfied, 5=very satisfied. Percentage of participants rated 4 and 5 are reported below | Per protocol | Posted | Number | percentage of subjects satisfied | 12 weeks |
|
|
|
| Secondary | Safety Assessment | Discomfort level during treatment using the Visual Analog Scale (VAS) and post-treatment skin reponses or side effects using a 0-3 severity scale. | Not Posted | 1, 4, 8, 12 weeks |
| Secondary | Subcutaneous Adipose Thickness | Ultrasound assisted measurement of adipose tissue thickness | Not Posted | 12 weeks |
| Secondary | Global Aesthetic Improvement Scale (GAIS) Score Post Treatment Assessed by Investigator for Determining Clinical Improvement | Mean Investigator improvement at 12 weeks using the GAIS Scale. *GAIS Scale: 1=Much Worse, 2=Worse, 3=No Improvement, 4=Improved, 5=Much Improved | Per protocol | Posted | Mean | Standard Deviation | units on a scale | 12 weeks |
|
|
|
| 0 |
| 60 |
| 26 |
| 60 |
| Tenderness | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Dysesthesia | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Itchiness | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Discoloration | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
Investigator shall notify Sponsor of the intent to publish or present independent Study Data, and agrees not to publish or publicly present and/or discuss such data, Investigator's current findings and/or the results of the Study independently without the express written consent of Sponsor, which consent may be withheld. Sponsor reserves the right to require Investigator to remove any/all confidential information from any/all publications.