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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01853397
Recruitment Status : Completed
First Posted : May 15, 2013
Results First Posted : March 27, 2015
Last Update Posted : April 16, 2015
Sponsor:
Information provided by (Responsible Party):
Valeant Pharmaceuticals ( Solta Medical )

Study Description
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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.

Condition or disease Intervention/treatment Phase
Subcutaneous Adipose Tissue Device: Liposonix System (Model 2) Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : April 2013
Actual Primary Completion Date : February 2014
Actual Study Completion Date : February 2014
Arms and Interventions
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Arm Intervention/treatment
Experimental: Treatment at level 1
Single treatment with Liposonix System (Model 2) using single pass technique at level 1 (180 J/cm2)
 Device: Liposonix System (Model 2)
Experimental: Treatment at level 2
Single treatment with Liposonix System (Model 2)using the single pass technique at treatment level 2 (140 J/cm2)
 Device: Liposonix System (Model 2)
Experimental: Treatment at level 3
Single treatment with Liposonix System (Model 2)using single pass technique at level 3 (120 J/cm2)
 Device: Liposonix System (Model 2)
Active Comparator: Treatment with 3 passes at 60 J/cm2
Single treatment with Liposonix System (Model 2) using grid repeat technique with 3 passes at 60 J/cm2 (180 J/cm2 total fluence)
 Device: Liposonix System (Model 2)


Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Change in Waist Circumference 4,8, and16 Weeks After Treatment as Compared to Baseline [ Time Frame: 4 weeks, 8 weeks, 16 weeks ]
    Change from baseline in waist circumference 4, 8, and 16 weeks after treatment was assessed by blinded evaluators.

  2. Investigator Assessment of Improvement Using Global Aesthetic Improvement Scale (GAIS) [ Time Frame: 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'.


  3. Subject Assessment of Improvement Using Global Aesthetic Improvement Scale (GAIS) [ Time Frame: 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'.

  4. Subject Satisfaction With Treatment [ Time Frame: 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').


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  • Subjects who are unable, or lack the capacity, to self consent
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01853397


Locations
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United States, California
Solta Medical Aesthetic Center
Hayward, California, United States, 94545
United States, Oregon
Jewell Plastic Surgery Center
Eugene, Oregon, United States, 97401
Sponsors and Collaborators
Solta Medical
Investigators
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Principal Investigator: Mark Jewell, MD Jewell Plastic Surgery Center
Principal Investigator: Ronald Wheeland, MD Solta Medical Aesthetic Center
More Information
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Responsible Party: Solta Medical
ClinicalTrials.gov Identifier: NCT01853397    
Other Study ID Numbers: 13-137-LP-H
First Posted: May 15, 2013    Key Record Dates
Results First Posted: March 27, 2015
Last Update Posted: April 16, 2015
Last Verified: March 2015