Females Scheduled to be Treated Using the MC1.
Conditions
Keywords
MC1 VASER VASERShape
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.
Interventions
DEVICEMC1 Ultrasonic Device
Ultrasonic and zonal massage device.
Sponsors
Sound Surgical Technologies, LLC.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 50 Years
Healthy volunteers
Yes
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
Countries
United States
Outcome results
None listed