Protocol To Evaluate Patient Measurements After Ultrasonic Treatment
| Tracking Information | |
|---|---|
| First Received Date ICMJE | June 14, 2011 |
| Last Updated Date | March 23, 2012 |
| Start Date ICMJE | June 2011 |
| Primary Completion Date | March 2012 (final data collection date for primary outcome measure) |
| Current Primary Outcome Measures ICMJE | Not Provided |
| Original Primary Outcome Measures ICMJE | Not Provided |
| Change History | Complete list of historical versions of study NCT01373827 on ClinicalTrials.gov Archive Site |
| Current Secondary Outcome Measures ICMJE | Not Provided |
| Original Secondary Outcome Measures ICMJE | Not Provided |
| Current Other Outcome Measures ICMJE | Not Provided |
| Original Other Outcome Measures ICMJE | Not Provided |
| Descriptive Information | |
| Brief Title ICMJE | Protocol To Evaluate Patient Measurements After Ultrasonic Treatment |
| Official Title ICMJE | Protocol To Evaluate Patient Measurements After Ultrasonic Treatment. |
| Brief Summary | Patients enrolled in this study will come from the Investigator's patient population and be ordinarily suitable for treatment using the MC1 device. The treatment they receive will be no different if they participate than if they do not. The study is only to observe the patients before, during and after their usual treatment. |
| Detailed Description | Not Provided |
| Study Type ICMJE | Observational |
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
| Target Follow-Up Duration | Not Provided |
| Biospecimen | Not Provided |
| Sampling Method | Non-Probability Sample |
| Study Population | All subjects presenting to the investigator for treatment using the MC1 are potential study candidates and will be screened for eligibility. Every effort will be made to establish eligibility of the participants before enrollment. Subjects who do not meet all inclusion/exclusion criteria will not be enrolled. Enrollment in the study occurs at the time the patient is randomized to the assigned treatment. |
| Condition ICMJE | Patients Treated With VaserShape MC1 |
| Intervention ICMJE | Device: VASERShape MC1
Use of the VASERShape MC1 device as part of routine practice |
| Study Group/Cohort (s) | MC1 Subjects
Intervention: Device: VASERShape MC1 |
| Publications * | Not Provided |
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* 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 | Completed |
| Enrollment ICMJE | 7 |
| Completion Date | March 2012 |
| Primary Completion Date | March 2012 (final data collection date for primary outcome measure) |
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female |
| Ages | 20 Years to 50 Years |
| Accepts Healthy Volunteers | Yes |
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
| Location Countries ICMJE | United States |
| Administrative Information | |
| NCT Number ICMJE | NCT01373827 |
| Other Study ID Numbers ICMJE | SST2011-2 |
| Has Data Monitoring Committee | No |
| Responsible Party | Roy G Geronemus, MD, Laser & Skin Surgery Center of New York |
| Study Sponsor ICMJE | Sound Surgical Technologies, LLC. |
| Collaborators ICMJE | Not Provided |
| Investigators ICMJE | Not Provided |
| Information Provided By | Sound Surgical Technologies, LLC. |
| Verification Date | March 2012 |
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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