Protocol To Evaluate Patient Measurements After Ultrasonic Treatment

NCT ID: NCT01373827

Last Updated: 2012-03-26

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 7 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-06-30
• Study Completion Date: 2012-03-31

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.

Conditions

Patients Treated With VaserShape MC1

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

MC1 Subjects

VASERShape MC1

Intervention Type: DEVICE

Use of the VASERShape MC1 device as part of routine practice

Interventions

VASERShape MC1

Use of the VASERShape MC1 device as part of routine practice

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Sound Surgical Technologies, LLC.

INDUSTRY

Sponsor Role: lead

Responsible Party

Laser & Skin Surgery Center of New York

Locations

Laser & Skin Surgery Center of New York

New York, New York, United States

Countries

United States

Other Identifiers

SST2011-2

Identifier Type: -

Identifier Source: org_study_id