Clinical trial NCT01260298: Protocol To Evaluate Patient Measurements After Ultrasonic Treatment
Official title: Protocol To Evaluate Patient Measurements After Ultrasonic Treatment.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Females Scheduled to be Treated Using the MC1.
Keywords: MC1 VASER VASERShape
Lead sponsor: Sound Surgical Technologies, LLC.
Sponsor class: INDUSTRY
First posted: 2010-12-15
Enrollment: 12
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Chestnut Hill
country: United States
facility: Skin Care Physicians
state: Massachusetts
Study officials:
affiliation: SkinCare Physicians
name: Michael Kaminer, MD
role: PRINCIPAL_INVESTIGATOR
References: