New York, New York 10016


Purpose:

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.


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.


Study is Available At:


Original ID:

SST2011-2


NCT ID:

NCT01373827


Secondary ID:


Study Acronym:


Brief Title:

Protocol To Evaluate Patient Measurements After Ultrasonic Treatment


Official Title:

Protocol To Evaluate Patient Measurements After Ultrasonic Treatment.


Overall Status:

Recruiting


Study Phase:

N/A


Genders:

Female


Minimum Age:

20 Years


Maximum Age:

50 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Sound Surgical Technologies, LLC.


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Observational


Study Design:

Observational Model: Cohort, Time Perspective: P


Number of Arms:

0


Number of Groups:

1


Total Enrollment:

10


Enrollment Type:

Anticipated


Overall Contact Information

Primary Contact:Jennifer Moreno
jmoreno@laserskinsurgery.com

Study Dates

Start Date:June 2011
Completion Date:September 2011
Completion Type:Anticipated
Primary Completion Date:August 2011
Primary Completion Type:Anticipated
Verification Date:June 2011
Last Changed Date:June 14, 2011
First Received Date:June 14, 2011

Study Outcomes

There are no available Study Outcomes

Study Interventions

Intervention Type:Device
Name:VASERShape MC1
Description:Use of the VASERShape MC1 device as part of routine practice
Arm Name:MC1 Subjects

Study Arms

Study Arm Type:Other
Arm Name:MC1 Subjects

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Sound Surgical Technologies, LLC.

Samples and Retentions

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.
Sample Method:Non-Probability Sample

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


If you would like to be contacted by the clinical trial representative please fill out the form below.