Protocol To Evaluate Patient Measurements After Ultrasonic Treatment

Completed

• Conditions: Females Scheduled to be Treated Using the MC1.
• Interventions: Device: MC1 Ultrasonic Device

• Registration Number: NCT01260298
• Lead Sponsor: Sound Surgical Technologies, LLC.

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 Timeline

• Study Start: 2010-12
• Study First Submitted: 2010-12-13
• Study First Submitted QC: 2010-12-14
• Study First Posted: 2010-12-15
• Status Verified: 2011-03
• Primary Completion: 2011-03
• Study Completion: 2011-03
• Last Update Submitted: 2011-03-09
• Last Update Posted: 2011-03-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 12

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
MC1 Ultrasonic Device	MC1 Ultrasonic Device	-

Trial Locations

Locations (1)

Skin Care Physicians; 🇺🇸 Chestnut Hill, Massachusetts, United States