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Protocol To Evaluate Patient Measurements After Ultrasonic Treatment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01260298
Recruitment Status : Completed
First Posted : December 15, 2010
Last Update Posted : March 11, 2011
Sponsor:
Information provided by:
Sound Surgical Technologies, LLC.

Tracking Information
First Submitted Date December 13, 2010
First Posted Date December 15, 2010
Last Update Posted Date March 11, 2011
Study Start Date December 2010
Actual Primary Completion Date March 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Protocol To Evaluate Patient Measurements After Ultrasonic Treatment
Official Title Protocol To Evaluate Patient Measurements After Ultrasonic Treatment.
Brief Summary The objective of this study is to observe body contour changes following treatment using the MC1 device.
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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Females Scheduled to be Treated Using the MC1.
Intervention Device: MC1 Ultrasonic Device
Ultrasonic and zonal massage device.
Other Names:
  • MC1
  • VASERShape
Study Groups/Cohorts MC1 Ultrasonic Device
Intervention: Device: MC1 Ultrasonic Device
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Estimated Enrollment
 (submitted: January 13, 2011)
12
Original Estimated Enrollment
 (submitted: December 14, 2010)
10
Actual Study Completion Date March 2011
Actual Primary Completion Date March 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  1. Is female.
  2. Is between 20 and 50 years of age, inclusive, on the day of enrolment.
  3. Has a BMI between 20 and 30 kg/m2.
  4. Is to be treated in the infra-scapular area using the MC1.
  5. Has never been treated with the MC1 before.

Exclusion Criteria:

  1. 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.
  2. 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.
  3. Keloid scars, hypertrophic scars or a history of abnormal healing.
  4. Thrombophlebitis.
  5. Bleeding or bruising disorders (e.g. idiopathic thrombocytopenic purpura, anticoagulated patients).
  6. Tissue ischemia in the area to be treated.
  7. Hypertension or abnormally high blood pressure.
  8. High cholesterol.
  9. Active collagen vascular disease (e.g. fibromyalgia, panniculitis, lupus etc.).
  10. Diabetes.
  11. Epilepsy.
  12. Tuberculosis.
  13. Auxiliary electric organs (such as pacemakers), metal or myoelectric prosthesis.
  14. Endocrine syndromes or thyroid hyperfunction.
  15. Any type of hemorrhagic (bleeding) status.
  16. 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).
  17. Hepatic or renal insufficiency.
  18. Bone, muscle or joint disease, dysfunction or healing in the area to be treated.
  19. Malignancy in the area to be treated.
  20. Laminectomy in the area to be treated. 5.2. Withdrawal and Replacement of Subjects
Sex/Gender
Sexes Eligible for Study: Female
Ages 20 Years to 50 Years   (Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01260298
Other Study ID Numbers SST2010-2
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Grant Palmer/Clinical Research, Sound Surgical Technologies, LLC
Study Sponsor Sound Surgical Technologies, LLC.
Collaborators Not Provided
Investigators
Principal Investigator: Michael Kaminer, MD SkinCare Physicians
PRS Account Sound Surgical Technologies, LLC.
Verification Date March 2011