An Evaluation of the Safety and Effectiveness of Treatment of Adipose Tissue With the Liposonix System (Model 2) Using a New Treatment Method

Solta Medical2 sites in 1 country72 target enrollmentApril 2013

ConditionsSubcutaneous Adipose Tissue

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Subcutaneous Adipose Tissue
Sponsor: Solta Medical
Enrollment: 72
Locations: 2
Primary Endpoint: Change in Waist Circumference 12 Weeks After Treatment as Compared to Baseline
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

April 2013

End Date

February 2014

Last Updated

11 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Solta Medical

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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 Criteria

•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

Outcomes

Primary Outcomes

Change in Waist Circumference 12 Weeks After Treatment as Compared to Baseline

Time Frame: 12 weeks

Change from baseline in waist circumference 12 weeks after treatment was assessed by blinded evaluators.

Secondary Outcomes

Change in Waist Circumference 4,8, and16 Weeks After Treatment as Compared to Baseline(4 weeks, 8 weeks, 16 weeks)
Investigator Assessment of Improvement Using Global Aesthetic Improvement Scale (GAIS)(4, 8, 12, and 16 weeks)
Subject Assessment of Improvement Using Global Aesthetic Improvement Scale (GAIS)(4, 8, 12, and 16 weeks)
Subject Satisfaction With Treatment(4, 8, 12, and 16 weeks)