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The objective of this study is to evaluate the safety and efficacy of the Trusculpt (Radio Frequency) device in the reduction of thigh circumference.
The primary efficacy variable for this study is the comparison of mean change in thigh circumference from baseline to 12 weeks between two arms. The primary research hypothesis is that the mean change in thigh circumference is ≥ 1 cm (indicating mean reduction).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treated Thigh | Experimental | Trusculpt (Radio Frequency) Device |
|
| Untreated Contra-lateral Thigh | No Intervention | To be used as the self control in this split body study. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trusculpt (Radio Frequency) Device | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change of Thigh Circumference From Baseline | Change in thigh circumference from baseline of the treated thigh compared to the non-treated contra-lateral side at 12 weeks post-final treatment. | Comparison of Baseline to 12 weeks post- final treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Brian Biesman, MD | Principal Investigator | |
| Barry DiBernardo, MD | Principal Investigator | |
| Stephen Ronan, MD | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cutera Research Center | Brisbane | California | 94005 | United States | ||
| New Jersey Plastic Surgery |
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| ID | Title | Description |
|---|---|---|
| FG000 | All Study Participants | Subjects received RF treatments on one upper thigh (lateral and/or frontal and/or medial and/or posterior sides) according to randomization assignment and the opposite thigh served as the control. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | All Enrolled Subjects | Subjects received RF treatments on one upper thigh (lateral and/or frontal and/or medial and/or posterior sides) according to randomization assignment and the opposite thigh served as the control. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 of Thigh Circumference From Baseline | Change in thigh circumference from baseline of the treated thigh compared to the non-treated contra-lateral side at 12 weeks post-final treatment. | Posted | Mean | Full Range | cm | Comparison of Baseline to 12 weeks post- final treatment |
|
12 weeks post final treatment
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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 | Treated Thigh | Trusculpt (Radio Frequency) Device | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Erythema | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Margot Doucette | Cutera | 415-657-5518 | mdoucette@cutera.com |
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| Montclair |
| New Jersey |
| 07042 |
| United States |
| Nashville Center for Laser and Facial Surgery | Nashville | Tennessee | 37203 | United States |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| 44 |
| 0 |
| 44 |
| 41 |
| 44 |
| EG001 | Untreated Thigh | No Treatment with RF device | 0 | 44 | 0 | 44 | 0 | 44 |
| Edema | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Lumps | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
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