Protocol To Evaluate Patient Measurements After Ultrasonic Treatment

NCT01373827 | Completed

• 1 other identifier: SST2011-2
• Study Type: observational
• Target: 7
• Locations: 1 country
• Sites: 1

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

Keywords

VASER; VASERShape; MC1; ultrasound

Study Arms (1)

MC1 Subjects

Device: VASERShape MC1

Interventions

VASERShape MC1 DEVICE

Use of the VASERShape MC1 device as part of routine practice

MC1 Subjects

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• Healthy Female between 20 and 50 years of age, inclusive, on the day of enrolment.
• Has a BMI between 20 and 30 kg/m2.
• Is to be treated in the posterior thigh / saddlebag area using the MC1.
• 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.)

You may not qualify if:

• 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.).
• Epilepsy.
• Tuberculosis.
• Auxiliary electric organs (such as pacemakers), metal or myoelectric prosthesis.
• Suffering from Endocrine syndromes or thyroid hyperfunction.
• 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).
• Bone, muscle or joint disease, dysfunction or healing in the area to be treated.
• Malignancy in the area to be treated.

Sponsors & Collaborators

• Sound Surgical Technologies, LLC.: lead

Study Sites (1)

Laser & Skin Surgery Center of New York

New York, New York, 10016, United States

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 14, 2011
• First Posted: June 15, 2011
• Study Start: June 1, 2011
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: March 26, 2012

Record last verified: 2012-03

Locations

US (1)