Protocol To Evaluate Patient Measurements After Ultrasonic Treatment

Completed

• Conditions: Patients Treated With VaserShape MC1
• Interventions: Device: VASERShape MC1

• Registration Number: NCT01373827
• Lead Sponsor: Sound Surgical Technologies, LLC.

Brief Summary

Patients enrolled in this study will come from the Investigator's patient population and be ordinarily suitable for treatment using the MC1 device. The treatment they receive will be no different if they participate than if they do not. The study is only to observe the patients before, during and after their usual treatment.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-06
• Study First Submitted: 2011-06-14
• Study First Submitted QC: 2011-06-14
• Study First Posted: 2011-06-15
• Status Verified: 2012-03
• Primary Completion: 2012-03
• Study Completion: 2012-03
• Last Update Submitted: 2012-03-23
• Last Update Posted: 2012-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 7

Inclusion Criteria

1. Healthy Female between 20 and 50 years of age, inclusive, on the day of enrolment.
2. Has a BMI between 20 and 30 kg/m2.
3. Is to be treated in the posterior thigh / saddlebag area using the MC1.
4. Has never been treated with the MC1 before.
5. Females who are post menopausal or using a medically acceptable form of birth control prior to study enrollment and during the course of the study. (i.e., condoms with spermicide, oral contraceptives contraceptive implants etc.)

Exclusion Criteria

1. Subject is lactating, has a positive pregnancy test within 7 days of planned study procedure (for female subjects of child-bearing potential), or intends to become pregnant during the study.
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, hypertorphic scars or a history of abnormal healing.
4. Any known bruising disorder, anticoagulative / thromboembolic condition , hemorrhagic (bleeding) status or use of anti coagulants.
5. Tissue ischemia in the area to be treated.
6. Suffering from concurrent conditions such as liver or kidney disorders, Hypertension or abnormally high blood pressure.
7. High cholesterol and/or diabetes.
8. Active collagen vascular disease (e.g. fibromyalgia, panniculitis, lupus etc.).
9. Epilepsy.
10. Tuberculosis.
11. Auxiliary electric organs (such as pacemakers), metal or myoelectric prosthesis.
12. Suffering from Endocrine syndromes or thyroid hyperfunction.
13. 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).
14. Bone, muscle or joint disease, dysfunction or healing in the area to be treated.
15. Malignancy in the area to be treated.
16. Laminectomy in the area to be treated.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
MC1 Subjects	VASERShape MC1	-

Trial Locations

Locations (1)

Laser & Skin Surgery Center of New York; 🇺🇸 New York, New York, United States