Multi-Center, Clinical Evaluation of the Cutera Secret RF Device
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ClinicalTrials.gov Identifier: NCT03424161 |
Recruitment Status : Unknown
Verified January 2018 by Cutera Inc..
Recruitment status was: Recruiting
First Posted : February 6, 2018
Last Update Posted : February 12, 2018
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Sponsor:
Cutera Inc.
Information provided by (Responsible Party):
Cutera Inc.
Tracking Information | |||||
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First Submitted Date ICMJE | January 25, 2018 | ||||
First Posted Date ICMJE | February 6, 2018 | ||||
Last Update Posted Date | February 12, 2018 | ||||
Actual Study Start Date ICMJE | January 10, 2018 | ||||
Estimated Primary Completion Date | April 2019 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
Device Safety [ Time Frame: through study completion, an average of 1+1/2 years ] Safety of the Cutera Secret RF laser as measured by the frequency and severity (0=none, 1=mild, 2=moderate, or 3=severe) of device related adverse events.
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Multi-Center, Clinical Evaluation of the Cutera Secret RF Device | ||||
Official Title ICMJE | Multi-Center, Clinical Evaluation of the Cutera Secret RF Device | ||||
Brief Summary | The objectives of this study are to evaluate the efficacy and safety of the Cutera Secret RF device. | ||||
Detailed Description | This is a multi-center, study in approximately 40 subjects, ages 18 to 65. Subjects may receive up to four treatments and will be followed at 4 and 12 weeks post the final treatment. A small subgroup of subjects may elect to have a biopsy of the treatment area prior to and after treatment. (Immediate, 72 Hours post initial treatment and 3 months post last treatment). | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Not Applicable | ||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Other |
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Condition ICMJE | Skin Quality | ||||
Intervention ICMJE | Device: Secret RF
Subjects may receive up to 4 treatments
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Study Arms ICMJE | Secret RF
Treatment with Secret RF for skin quality
Intervention: Device: Secret RF
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Unknown status | ||||
Estimated Enrollment ICMJE |
40 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | May 2019 | ||||
Estimated Primary Completion Date | April 2019 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 65 Years (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | Yes | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03424161 | ||||
Other Study ID Numbers ICMJE | C-18-SRF01 | ||||
Has Data Monitoring Committee | Not Provided | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Cutera Inc. | ||||
Study Sponsor ICMJE | Cutera Inc. | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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PRS Account | Cutera Inc. | ||||
Verification Date | January 2018 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |