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Protocol To Evaluate Patient Measurements After Ultrasonic Treatment

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ClinicalTrials.gov Identifier: NCT01260298
Recruitment Status : Completed
First Posted : December 15, 2010
Last Update Posted : March 11, 2011
Sponsor:
Information provided by:

Study Description
Brief Summary:
The objective of this study is to observe body contour changes following treatment using the MC1 device.

Condition or disease Intervention/treatment
Females Scheduled to be Treated Using the MC1. Device: MC1 Ultrasonic 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 Design

Study Type : Observational
Estimated Enrollment : 12 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Protocol To Evaluate Patient Measurements After Ultrasonic Treatment.
Study Start Date : December 2010
Primary Completion Date : March 2011
Study Completion Date : March 2011
Groups and Cohorts

Group/Cohort Intervention/treatment
MC1 Ultrasonic Device Device: MC1 Ultrasonic Device
Ultrasonic and zonal massage device.
Other Names:
  • MC1
  • VASERShape


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes 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:

  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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Grant Palmer/Clinical Research, Sound Surgical Technologies, LLC
ClinicalTrials.gov Identifier: NCT01260298     History of Changes
Other Study ID Numbers: SST2010-2
First Posted: December 15, 2010    Key Record Dates
Last Update Posted: March 11, 2011
Last Verified: March 2011

Keywords provided by Sound Surgical Technologies, LLC.:
MC1 VASER VASERShape