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The study was terminated because the preliminary data did not indicate efficacy.
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The purpose of this study is to evaluate the Cutera radio frequency (RF) device for the new indication of reduction of thigh circumference.
The purpose of this study is to evaluate the Cutera radio frequency device for the new indication of reduction of thigh circumference.
At investigator's discretion, each subject will receive up to three treatments on one thigh and will be scheduled for two follow-up visits after the final treatment. The treated thigh will be clinically evaluated for side effects and both treated and untreated control thigh will be measured and photographed at each visit for analysis. Subjects will also be weighted at each visit and asked to fill out a survey during follow-up visits.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treated Thigh | Experimental | The thigh treated with the RF device |
|
| Untreated Thigh | No Intervention | The untreated thigh |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cutera Radio Frequency Device | Device | Up to three treatments, one pass, dosage range of 15-60 kJ. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Difference in Circumference of Upper Thigh Between Treated and Untreated Control Arms | Mean difference of change from baseline between two arms: [Treated arm - Untreated arm] | Baseline and 6 months post final treatment |
| Difference in Circumference of Mid Thigh Between Treated and Untreated Control Arms | Mean difference of change from baseline between two arms: [Treated arm - Untreated arm] | Baseline and 6 months post final treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Subject Satisfaction | Baseline and 6 months post final treatment | |
| Adverse Events | At each visit (treatment and follow-up) or until resolution of AEs |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stephen J. Ronan, MD | Principal Investigator | |
| Jacqueline Calkin, MD | Principal Investigator | |
| Christine Lee, MD | Principal Investigator | |
| Scott Kramer, MD | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Blackhawk Plastic Surgery | Danville | California | 94506 | United States |
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The study subjects were recruited in the medical clinic 01/30/09 through 04/07/09.
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| ID | Title | Description |
|---|---|---|
| FG000 | Treated and Untreated Thigh | Circumference measurement of RF treated thigh compared to untreated thigh (average of 2.8 treatments and average dosage of 27 kJ) on the same subject |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Treated And Untreated Thigh | Treated and untreated arms (left and right thighs) on the same subject. |
| 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 Circumference of Upper Thigh Between Treated and Untreated Control Arms | Mean difference of change from baseline between two arms: [Treated arm - Untreated arm] | Posted | Mean | Standard Deviation | cm | Baseline and 6 months post final treatment | Upper Thigh | Participants |
|
|
6 months
Subjects were assessed and followed up for adverse events at 6 weeks, 3 months and 6 months after the RF 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 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Erythema | Injury, poisoning and procedural complications | Systematic Assessment |
Early termination of the study resulting in analysis of small numbers of subjects, and technical issues with repeatability and reproducibility of circumference measurements leading to termination.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ayse Turley, Clinical Development Researcher | Cutera Inc. | 415-657-5665 | aturley@cutera.com |
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| ID | Term |
|---|---|
| D000071697 | Cellulite |
| ID | Term |
|---|---|
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Upper Thigh |
|
|
| Secondary | Subject Satisfaction | Data was not collected due to termination. | Posted | Number | Participants | Baseline and 6 months post final treatment |
|
|
| Secondary | Adverse Events | Posted | Number | Event | At each visit (treatment and follow-up) or until resolution of AEs | Thighs (left or right) | Participants |
|
|
|
| Primary | Difference in Circumference of Mid Thigh Between Treated and Untreated Control Arms | Mean difference of change from baseline between two arms: [Treated arm - Untreated arm] | Posted | Mean | Standard Deviation | cm | Baseline and 6 months post final treatment | Mid Thigh | Participants |
|
|
|
| 0 |
| 4 |
| 3 |
| 4 |
| Edema | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Bruising | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Lumps | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Sensitivity | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Discomfort | Injury, poisoning and procedural complications | Systematic Assessment |
|
Prepare the study results for publication and presentation in cooperation with Cutera. The Doctor will not publish or present the results of the Study, or speak publicly about it, unless Cutera has first had a reasonable opportunity to review and comment on the contents of the proposed presentation or publication.
| Title | Measurements |
|---|
|
| Lumps |
|
| Sensitivity |
|
| Discomfort |
|