Status:
COMPLETED
Evaluation of the Treatment of Adipose Tissue With Liposonix System (Model 2) Using a New Treatment Method
Lead Sponsor:
Solta Medical
Conditions:
Subcutaneous Adipose Tissue
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
The purpose of this study is to evaluate the safety, efficacy, and tolerability of treatment with the Liposonix System (Model 2)using a single pass technique.
Eligibility Criteria
Inclusion
- Male or female, 18 to 65 years of age
- Body Mass Index of ≤30 kg/m2
- Thickness of subcutaneous adipose tissue in the anticipated treatment area of ≥ 2.3 cm
- Subjects must agree to not alter their normal and regular diet or exercise routines during the course of the study
- Subject must understand the nature of the study and sign an IRB approved Informed Consent
Exclusion
- Subject is pregnant
- Subject is diagnosed with coagulation disorders or are receiving anticoagulant therapy or medications or dietary supplements which impede coagulation or platelet aggregation
- Subject has diabetes or cardiovascular disease
- Subject has had prior aesthetic procedures to the region to be treated
- Subject has had previous open or laparoscopic surgery in the anticipated treatment area
- Subject is on prescription or over the counter weight reduction medication or programs, or had weight reduction procedures
- Subjects undergoing chronic steroid or immunosuppressive therapy
- Subject has cardiac pacemakers or any implantable electrical device
- Subject has a History of cancer
- Subject has sensory loss or dysesthesia in the area to be treated
- Subjects who are unable, or lack the capacity, to self consent
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2014
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT01853397
Start Date
April 1 2013
End Date
February 1 2014
Last Update
April 16 2015
Active Locations (2)
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1
Solta Medical Aesthetic Center
Hayward, California, United States, 94545
2
Jewell Plastic Surgery Center
Eugene, Oregon, United States, 97401