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

Subcutaneous Adipose Tissue Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01853397
• Other study ID #: 13-137-LP-H
• Status: Completed
• Phase: N/A
• First received: May 8, 2013
• Last updated: March 26, 2015
• Start date: April 2013
• Est. completion date: February 2014

Study information

• Verified date: March 2015
• Source: Valeant Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Subcutaneous Adipose Tissue

Intervention

Device:
• Liposonix System (Model 2)

Locations

Country	Name	City	State
United States	Jewell Plastic Surgery Center	Eugene	Oregon
United States	Solta Medical Aesthetic Center	Hayward	California

Sponsors (1)

Lead Sponsor	Collaborator
Solta Medical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	12 weeks	No
Secondary	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.	4 weeks, 8 weeks, 16 weeks	No
Secondary	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'.	4, 8, 12, and 16 weeks	No
Secondary	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'.	4, 8, 12, and 16 weeks	No
Secondary	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').	4, 8, 12, and 16 weeks	No