Protocol To Evaluate Patient Measurements After Ultrasonic Treatment

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

12 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-12-31

Study Completion Date

2011-03-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Females Scheduled to be Treated Using the MC1.

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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MC1 Ultrasonic Device

Intervention Type DEVICE

Ultrasonic and zonal massage device.

Interventions

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MC1 Ultrasonic Device

Ultrasonic and zonal massage device.

Intervention Type DEVICE

Other Intervention Names

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MC1 VASERShape

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes