Protocol To Evaluate Patient Measurements After Ultrasonic Treatment

Completed

Conditions studied: Females Scheduled to be Treated Using the MC1.

In brief

The objective of this study is to observe body contour changes following treatment using the MC1 device.

Key facts

Study ID

NCT01260298

Run by

Sound Surgical Technologies, LLC.

People needed

12

Starts

2010-12-01

Expected to finish

2011-03-01

Last updated by the study team

2011-03-11

Who can join

Age: 20 and older, up to 50. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Skin Care Physicians — Chestnut Hill, Massachusetts, United States

Full record on ClinicalTrials.gov

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