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

Solta Medical72 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Subcutaneous Adipose Tissue

Interventions

Liposonix System (Model 2)DEVICE

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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 * Subjects who are unable, or lack the capacity, to self consent

Locations (2)

Solta Medical Aesthetic Center

Hayward, California, United States

Jewell Plastic Surgery Center

Eugene, Oregon, United States

Outcomes

Primary Outcomes

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

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

Time frame: 12 weeks

Secondary Outcomes

Change in Waist Circumference 4,8, and16 Weeks After Treatment as Compared to Baseline

Change from baseline in waist circumference 4, 8, and 16 weeks after treatment was assessed by blinded evaluators.

Time frame: 4 weeks, 8 weeks, 16 weeks

Investigator Assessment of Improvement Using Global Aesthetic Improvement Scale (GAIS)

GAIS evaluations were performed by Investigators at the 4, 8, 12, and 16 week visits. Investigators used direct visual assessment (live assessment) compared to photographs of subjects taken before treatment (baseline) to assess improvement in the treatment area. Scoring was based upon a five point grading System: 5 - Much Improved, 4 - Improved, 3 - No Change, 2 - Worse, or 1 - Much Worse. The definition of an improvement of the GAIS score included either a GAIS score of 'Improved' or 'Much Improved'.

Time frame: 4, 8, 12, and 16 weeks

Subject Assessment of Improvement Using Global Aesthetic Improvement Scale (GAIS)

Subjects self-assessed improvement in the treatment area and assigned a GAIS score at each visit. Scoring was based upon a five point grading System: 5 - Much Improved, 4 - Improved, 3 - No Change, 2 - Worse, or 1 - Much Worse. The definition of an improvement of the GAIS score included either a GAIS score of 'Improved' or 'Much Improved'.

Time frame: 4, 8, 12, and 16 weeks

Subject Satisfaction With Treatment

Subjects rated their satisfaction with treatment results using a 5-point Likert Satisfaction Scale (5: very satisfied; 4: satisfied; 3: neither satisfied nor dissatisfied; 2: dissatisfied; 1: very dissatisfied). The subject satisfaction score was analyzed as the proportion of subjects showing improvement as defined as a score of 4 or greater ('satisfied' or 'very satisfied').

Data from ClinicalTrials.gov

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