Protocol To Evaluate Patient Measurements After Ultrasonic Treatment
This study has been completed.
Sponsor:
Sound Surgical Technologies, LLC.
Information provided by:
Sound Surgical Technologies, LLC.
ClinicalTrials.gov Identifier:
NCT01260298
First received: December 13, 2010
Last updated: March 9, 2011
Last verified: March 2011
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Purpose
The objective of this study is to observe body contour changes following treatment using the MC1 device.
| Condition | Intervention |
|---|---|
|
Females Scheduled to be Treated Using the MC1. |
Device: MC1 Ultrasonic Device |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Protocol To Evaluate Patient Measurements After Ultrasonic Treatment. |
Further study details as provided by Sound Surgical Technologies, LLC.:
| Estimated Enrollment: | 12 |
| Study Start Date: | December 2010 |
| Study Completion Date: | March 2011 |
| Primary Completion Date: | March 2011 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
| MC1 Ultrasonic Device |
Device: MC1 Ultrasonic Device
Ultrasonic and zonal massage device.
Other Names:
|
Detailed Description:
The purpose of this research study is to observe body contour changes following treatment using the MC1 device. The MC1 System is FDA cleared for relief of minor muscle aches, pain and muscle spasm, temporary improvement in local blood circulation, and temporary reduction in the appearance of cellulite.
Eligibility| Ages Eligible for Study: | 20 Years to 50 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Study Population
Female between the ages of 20 and 50 years with BMI between 20 and 30 who are scheduled to be treated using the MC1 device.
Criteria
Inclusion Criteria:
- Is female.
- Is between 20 and 50 years of age, inclusive, on the day of enrolment.
- Has a BMI between 20 and 30 kg/m2.
- Is to be treated in the infra-scapular area using the MC1.
- Has never been treated with the MC1 before.
Exclusion Criteria:
- Patient is lactating, has a positive pregnancy test within 7 days of planned study procedure (for female patients of child-bearing potential), or intends to become pregnant during the study or is not using effective methods to prevent pregnancy.
- Currently enrolled in another device or drug study that has not completed the required follow-up period, or has completed all other study-required follow-up less than 30 days before enrolment in this study.
- Keloid scars, hypertrophic scars or a history of abnormal healing.
- Thrombophlebitis.
- Bleeding or bruising disorders (e.g. idiopathic thrombocytopenic purpura, anticoagulated patients).
- Tissue ischemia in the area to be treated.
- Hypertension or abnormally high blood pressure.
- High cholesterol.
- Active collagen vascular disease (e.g. fibromyalgia, panniculitis, lupus etc.).
- Diabetes.
- Epilepsy.
- Tuberculosis.
- Auxiliary electric organs (such as pacemakers), metal or myoelectric prosthesis.
- Endocrine syndromes or thyroid hyperfunction.
- Any type of hemorrhagic (bleeding) status.
- Active skin infection, any infection in the treated area within the last 30 days or skin disease in the area to be treated (e.g. eczema, psoriasis, urticaria, dermographism).
- Hepatic or renal insufficiency.
- Bone, muscle or joint disease, dysfunction or healing in the area to be treated.
- Malignancy in the area to be treated.
- Laminectomy in the area to be treated. 5.2. Withdrawal and Replacement of Subjects
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01260298
Locations
| United States, Massachusetts | |
| Skin Care Physicians | |
| Chestnut Hill, Massachusetts, United States, 02467 | |
Sponsors and Collaborators
Sound Surgical Technologies, LLC.
Investigators
| Principal Investigator: | Michael Kaminer, MD | SkinCare Physicians |
More Information
No publications provided
| Responsible Party: | Grant Palmer/Clinical Research, Sound Surgical Technologies, LLC |
| ClinicalTrials.gov Identifier: | NCT01260298 History of Changes |
| Other Study ID Numbers: | SST2010-2 |
| Study First Received: | December 13, 2010 |
| Last Updated: | March 9, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Sound Surgical Technologies, LLC.:
|
MC1 VASER VASERShape |
ClinicalTrials.gov processed this record on May 19, 2013