Protocol To Evaluate Patient Measurements After Ultrasonic Treatment

Protocol To Evaluate Patient Measurements After Ultrasonic Treatment.

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.

Study Overview

• Status: Completed
• Conditions: Patients Treated With VaserShape MC1
• Intervention / Treatment: Device: VASERShape MC1

• Study Type: Observational
• Enrollment (Actual): 7

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • Laser & Skin Surgery Center of New York

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

All subjects presenting to the investigator for treatment using the MC1 are potential study candidates and will be screened for eligibility. Every effort will be made to establish eligibility of the participants before enrollment. Subjects who do not meet all inclusion/exclusion criteria will not be enrolled. Enrollment in the study occurs at the time the patient is randomized to the assigned treatment.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
MC1 Subjects	Device: VASERShape MC1; Use of the VASERShape MC1 device as part of routine practice

Collaborators and Investigators

• Sponsor: Sound Surgical Technologies, LLC.

Study record dates

Study Major Dates

• Study Start: June 1, 2011
• Primary Completion (Actual): March 1, 2012
• Study Completion (Actual): March 1, 2012

Study Registration Dates

• First Submitted: June 14, 2011
• First Submitted That Met QC Criteria: June 14, 2011
• First Posted (Estimate): June 15, 2011

Study Record Updates

• Last Update Posted (Estimate): March 26, 2012
• Last Update Submitted That Met QC Criteria: March 23, 2012
• Last Verified: March 1, 2012

More Information

Terms related to this study

• Keywords: ultrasound; VASER; VASERShape; MC1
• Other Study ID Numbers: SST2011-2