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

Not Applicable

Completed

• Conditions: Subcutaneous Adipose Tissue
• Interventions: Device: Liposonix System (Model 2)

• Registration Number: NCT01853397
• Lead Sponsor: Solta Medical

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-04
• Study First Submitted: 2013-05-08
• Study First Submitted QC: 2013-05-10
• Study First Posted: 2013-05-15
• Primary Completion: 2014-02
• Study Completion: 2014-02
• Status Verified: 2015-03
• Results First Submitted: 2015-03-17
• Results First Submitted QC: 2015-03-17
• Last Update Submitted: 2015-03-26
• Results First Posted: 2015-03-27
• Last Update Posted: 2015-04-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment at level 2	Liposonix System (Model 2)	Single treatment with Liposonix System (Model 2)using the single pass technique at treatment level 2 (140 J/cm2)
Treatment at level 3	Liposonix System (Model 2)	Single treatment with Liposonix System (Model 2)using single pass technique at level 3 (120 J/cm2)
Treatment at level 1	Liposonix System (Model 2)	Single treatment with Liposonix System (Model 2) using single pass technique at level 1 (180 J/cm2)
Treatment with 3 passes at 60 J/cm2	Liposonix System (Model 2)	Single treatment with Liposonix System (Model 2) using grid repeat technique with 3 passes at 60 J/cm2 (180 J/cm2 total fluence)

Primary Outcome Measures

Name	Time	Method
Change in Waist Circumference 12 Weeks After Treatment as Compared to Baseline	12 weeks	Change from baseline in waist circumference 12 weeks after treatment was assessed by blinded evaluators.

Secondary Outcome Measures

Name	Time	Method
Change in Waist Circumference 4,8, and16 Weeks After Treatment as Compared to Baseline	4 weeks, 8 weeks, 16 weeks	Change from baseline in waist circumference 4, 8, and 16 weeks after treatment was assessed by blinded evaluators.
Investigator Assessment of Improvement Using Global Aesthetic Improvement Scale (GAIS)	4, 8, 12, and 16 weeks	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'.
Subject Assessment of Improvement Using Global Aesthetic Improvement Scale (GAIS)	4, 8, 12, and 16 weeks	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'.
Subject Satisfaction With Treatment	4, 8, 12, and 16 weeks	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').

Trial Locations

Locations (2)

Jewell Plastic Surgery Center; 🇺🇸 Eugene, Oregon, United States

Solta Medical Aesthetic Center; 🇺🇸 Hayward, California, United States