- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01853397
Evaluation of the Treatment of Adipose Tissue With Liposonix System (Model 2) Using a New Treatment Method
An Evaluation of the Safety and Effectiveness of Treatment of Adipose Tissue With the Liposonix System (Model 2) Using a New Treatment Method
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
-
Hayward, California, United States, 94545
- Solta Medical Aesthetic Center
-
-
Oregon
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Eugene, Oregon, United States, 97401
- Jewell Plastic Surgery Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / 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)
|
|
Experimental: Treatment at level 2
Single treatment with Liposonix System (Model 2)using the single pass technique at treatment level 2 (140 J/cm2)
|
|
Experimental: Treatment at level 3
Single treatment with Liposonix System (Model 2)using single pass technique at level 3 (120 J/cm2)
|
|
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)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
4 weeks, 8 weeks, 16 weeks
|
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'. |
4, 8, 12, and 16 weeks
|
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, 8, 12, and 16 weeks
|
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').
|
4, 8, 12, and 16 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Mark Jewell, MD, Jewell Plastic Surgery Center
- Principal Investigator: Ronald Wheeland, MD, Solta Medical Aesthetic Center
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 13-137-LP-H
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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