Protocol To Evaluate Patient Measurements After Ultrasonic Treatment

This study has been completed.
Sponsor:
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
  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:
  • MC1
  • VASERShape

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:

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 30, 2014