Protocol To Evaluate Patient Measurements After Ultrasonic Treatment.

Sound Surgical Technologies, LLC.1 site in 1 country7 target enrollmentJune 2011

ConditionsPatients Treated With VaserShape MC1

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Patients Treated With VaserShape MC1
Sponsor: Sound Surgical Technologies, LLC.
Enrollment: 7
Locations: 1
Status: Completed
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

June 2011

End Date

March 2012

Last Updated

14 years ago

Study Type

Observational

Sex

Female

Investigators

Sponsor

Sound Surgical Technologies, LLC.

Eligibility Criteria

Inclusion Criteria

•Healthy Female between 20 and 50 years of age, inclusive, on the day of enrolment.
•Has a BMI between 20 and 30 kg/m
•Is to be treated in the posterior thigh / saddlebag area using the MC
•Has never been treated with the MC1 before.
•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

•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.
•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.
•Keloid scars, hypertorphic scars or a history of abnormal healing.
•Any known bruising disorder, anticoagulative / thromboembolic condition , hemorrhagic (bleeding) status or use of anti coagulants.
•Tissue ischemia in the area to be treated.
•Suffering from concurrent conditions such as liver or kidney disorders, Hypertension or abnormally high blood pressure.
•High cholesterol and/or diabetes.
•Active collagen vascular disease (e.g. fibromyalgia, panniculitis, lupus etc.).
•Tuberculosis.
•Auxiliary electric organs (such as pacemakers), metal or myoelectric prosthesis.