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
To evaluate the safety and efficacy of the Cutera truSculpt radiofrequency device for circumferential reduction.
The objectives of this study are to evaluate efficacy and safety of treatment with the Cutera truSculpt RF device for circumferential reduction in the abdominal and flank region.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Active Comparator | truSculpt rf device, therapeutic settings |
|
| Sham | Sham Comparator | truSculpt rf device, non-therapeutic settings |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| truSculpt rf device | Device | radiofrequency device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Difference in Circumferential Measurement Related to Sham and Therapeutic Group at 12 Weeks Post-treatment | Change in Abdominal Circumferential Measurement Related to Sham and Therapeutic Group at 12 Weeks Post-treatment minus Baseline Measurement | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Subject Assessment of Improvement for Both Sham Group and Therapeutic Group at 12 Weeks Post-treatment. | Comparison of the average subject improvement score for the sham group and the therapeutic group at 12 weeks post-treatment using a 0 - 4 improvement scale where 0 equals "no change" and 4 equals "Very Significant Improvement". | 12 weeks |
Not provided
Inclusion Criteria:
Subject must agree to not undergo any other procedure(s) in the abdominal and flank region during the study period.
Subject must be able to read, understand and sign the Informed Consent Form. Subject must adhere to the follow-up schedule and study instructions. Subject must adhere to the same diet and/or exercise routine throughout the study, and agree to maintain the same weight throughout the study, within 5% of baseline weight measurement.
Willing to have digital photographs taken of the treatment area and agree to use of photographs for presentation, educational or marketing purposes.
Post-menopausal or surgically sterilized, or using a medically acceptable form of birth control at least 3 months prior to enrollment and during the entire course of the study, and no plans to become pregnant.
Exclusion Criteria:
Any type of prior cosmetic treatment to the target area within 12 months of study participation e.g., radiofrequency, cryolysis or light-based treatments.
Any prior invasive cosmetic surgery to the target area, such as liposuction. Currently taking medications or supplements for weight-loss or metabolism support/enhancement or has a history of taking such medications or supplements within 3 months.
Has a pacemaker, internal defibrillator, implantable cardioverter-defibrillator, nerve stimulator implant, cochlear implant or any other electronically, magnetically or mechanically activated implant.
Has metal implant(s) within the body, such as surgical clips, plates and screws, intrauterine device (IUD), artificial heart valves or artificial joints.
Significant concurrent illness, such as diabetes mellitus, cardiovascular disease, peripheral vascular disease or pertinent neurological disorders.
Diagnosed or documented immune system disorders. History of any disease or condition that could impair wound healing. History of diseases stimulated by heat, such as recurrent herpes zoster in the treatment area, unless treatment is conducted following a prophylactic regimen.
History of keloid formation, hypertrophic scarring or abnormal/delayed wound healing.
Infection, dermatitis, rash or other skin abnormality in the target area. Currently undergoing systemic chemotherapy or radiation treatment for cancer, or history of treatment in the target area within 3 months of study participation.
Pregnant or currently breastfeeding. As per the Investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cutera Research Center | Brisbane | California | 94005 | United States |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Treatment | truSculpt rf device, therapeutic settings truSculpt rf device: radiofrequency device |
| FG001 | Sham | truSculpt rf device, non-therapeutic settings truSculpt rf device: radiofrequency device |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Treatment | truSculpt rf device, therapeutic settings truSculpt rf device: radiofrequency device |
| BG001 | Sham | truSculpt rf device, non-therapeutic settings truSculpt rf device: radiofrequency device |
| 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 | Difference in Circumferential Measurement Related to Sham and Therapeutic Group at 12 Weeks Post-treatment | Change in Abdominal Circumferential Measurement Related to Sham and Therapeutic Group at 12 Weeks Post-treatment minus Baseline Measurement | Posted | Mean | Standard Error | cm | 12 weeks |
|
Not provided
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 | Treatment | truSculpt rf device, therapeutic settings truSculpt rf device: radiofrequency device |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Erythema | Skin and subcutaneous tissue disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lourdes Moldre, NP | Cutera | 415-971-5118 | lmoldre@cutera.com |
Not provided
Not provided
Not provided
Not provided
Not provided
| Subject Satisfaction Level for Both Sham Group and Therapeutic Group at 12 Weeks Post-treatment. |
Comparison of the average subject satisfaction level for the sham group and therapeutic group at 12 weeks post-treatment, using a 1 - 5 scale where 1 equals "very dissatisfied" and 5 equals "very satisfied". |
| 12 weeks |
| Subject Discomfort and Pain Levels During Treatment | Comparison of the average pain levels during treatment for the sham group and therapeutic group at 12 weeks post-treatment, using a 0 - 10 scale where 0 equals "No pain" and 10 equals "Worst possible pain". | 12 weeks |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Units | Counts |
|---|
| Participants |
|
|
| Secondary | Subject Assessment of Improvement for Both Sham Group and Therapeutic Group at 12 Weeks Post-treatment. | Comparison of the average subject improvement score for the sham group and the therapeutic group at 12 weeks post-treatment using a 0 - 4 improvement scale where 0 equals "no change" and 4 equals "Very Significant Improvement". | Posted | Mean | Standard Deviation | units on a scale | 12 weeks |
|
|
|
| Secondary | Subject Satisfaction Level for Both Sham Group and Therapeutic Group at 12 Weeks Post-treatment. | Comparison of the average subject satisfaction level for the sham group and therapeutic group at 12 weeks post-treatment, using a 1 - 5 scale where 1 equals "very dissatisfied" and 5 equals "very satisfied". | Posted | Mean | Standard Deviation | units on a scale | 12 weeks |
|
|
|
| Secondary | Subject Discomfort and Pain Levels During Treatment | Comparison of the average pain levels during treatment for the sham group and therapeutic group at 12 weeks post-treatment, using a 0 - 10 scale where 0 equals "No pain" and 10 equals "Worst possible pain". | Posted | Mean | Standard Deviation | units on a scale | 12 weeks |
|
|
|
| 0 |
| 47 |
| 47 |
| 47 |
| EG001 | Sham | truSculpt rf device, non-therapeutic settings truSculpt rf device: radiofrequency device | 0 | 23 | 23 | 23 |
| Edema | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
Not provided
Not provided
Not provided