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This is a prospective, controlled, multi-center study. Patients will be enrolled and treated with a radiofrequency device in this study if they have unwanted fat in the flank (love handle) area.
Subjects are to be enrolled in this clinical study if they are 18 - 55 years old. A maximum of 55 subjects will be enrolled at up to 6 study centers. Subjects will receive up to 5 treatments with the TempSure® Firm on one flank. The other flank will be left untreated to serve a control. Subject will be required to return for follow-up visits at 6 weeks and at 12 weeks after the subject's final treatment. All subjects will receive a phone call 1 week (1-10 days) post each treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All study participants | Experimental | Subjects will receive treatments with the RF device on one flank. The other flank will be left untreated to serve a control. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TempSure | Device | Non-invasive radiofrequency treatments |
|
| Measure | Description | Time Frame |
|---|---|---|
| % of Photos Identified Correctly When Comparing 12 Week Follow Up to Baseline | Correct identification of pre-treatment images vs. the 12-week follow up images by blinded evaluators. | 12 Week Follow Up |
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Inclusion Criteria:
Exclusion Criteria:
Cautionary Criteria:
NOTE: This device has not been tested on patients implanted with electronic devices that receive or emit signals, such as: Pacemakers, Implantable Cardiac Defibrillators (ICD), or Cardiac Resynchronization Therapy (CRT) devices.
Autoimmune Disease Diabetic Herpes Simplex
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| Name | Affiliation | Role |
|---|---|---|
| Jennifer Civiok | Cynosure, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maryland Dermatology Laser, Skin, & Vein Institute, LLC. | Hunt Valley | Maryland | 21030 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31896400 | Background | Gupta V, Sharma VK. Skin typing: Fitzpatrick grading and others. Clin Dermatol. 2019 Sep-Oct;37(5):430-436. doi: 10.1016/j.clindermatol.2019.07.010. Epub 2019 Jul 17. |
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| ID | Title | Description |
|---|---|---|
| FG000 | All Study Participants | Subjects will receive treatments with the RF device on one flank. The other flank will be left untreated to serve a control. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | RF Device Arm | Single arm, self controlled. TempSure: Non-invasive radiofrequency treatments |
| 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 | % of Photos Identified Correctly When Comparing 12 Week Follow Up to Baseline | Correct identification of pre-treatment images vs. the 12-week follow up images by blinded evaluators. | 1 subject attended the 12 week follow up so was considered complete, but did not have pictures taken for this outcome measure. | Posted | Number | % of photos identified correctly | 12 Week Follow Up | photographs | photographs |
|
|
Adverse events were collected throughout subject participation in the study, approximately 6 months.
Only subjects who received treatment on the treatment area observed adverse events (not on the control flank). Since no treatment was conducted on the control flanks, no adverse events can or should be expected for them.
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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 | RF Device | Subjects received treatment on this flank with the RF 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 | |
|---|---|---|---|---|
| Jamie Trimper | Cynosure | (978) 256-4200 | jamie.trimper@cynosure.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 | Sep 24, 2020 | Apr 6, 2022 | Prot_SAP_000.pdf |
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| JUVA Skin & Laser Center |
| New York |
| New York |
| 10022 |
| United States |
| Jeremy A Brauer MD PC | Rye | New York | 10580 | United States |
| Saluja Cosmetic and Laser Center | Huntersville | North Carolina | 28078 | United States |
| Dermatology Associates of Plymouth Meeting, P.C. | Plymouth Meeting | Pennsylvania | 19462 | United States |
| McDaniel Institute of Anti-Aging Research | Virginia Beach | Virginia | 23462 | United States |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| FitzPatrick Skin Type | The Fitzpatrick Skin Score is used to determine skin color. It is a numerical system that classifies skin into six types (Type I, Type II, Type III, Type IV, Type V and Type VI) based on the numerical score achieved (ranging from 0 to 36). The lower the score (and skin type number), the fairer the skin. The higher the score (and skin type number), the more deeply pigmented the skin is. The scale comes used is cited in the reference section | Count of Participants | Participants |
|
| Participants |
|
| photographs |
|
|
| 65 |
| 0 |
| 65 |
| 10 |
| 65 |
| EG001 | Control | Subjects received treatments on one flank, and their other flank (which was untreated) was used as the control. No intervention or treatment occurred on this flank. | 0 | 65 | 0 | 65 | 0 | 65 |
| edema | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| pain | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
The PI cannot disclose confidential or proprietary information until after it becomes generally known or available to the public.