N/A
N=72
Evaluation of the Treatment of Adipose Tissue With Liposonix System (Model 2) Using a New Treatment Method
Subcutaneous Adipose Tissue
Bottom Line
View on ClinicalTrials.gov: NCT01853397 ↗Enrolled (actual)
72
Serious AEs
0.0%
Results posted
Mar 2015
Primary outcome: Primary: Change in Waist Circumference 12 Weeks After Treatment as Compared to Baseline — -1.6; -.96; -1.4; -1.2 cm
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Liposonix System (Model 2) (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Solta Medical
- Primary completion
- Feb 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Waist Circumference 12 Weeks After Treatment as Compared to Baseline |
-1.6; -.96; -1.4; -1.2 | — |
| SECONDARY Change in Waist Circumference 4,8, and16 Weeks After Treatment as Compared to Baseline |
-0.66; -0.73; -0.86; -0.44; -0.76; -1.3 | — |
| SECONDARY Investigator Assessment of Improvement Using Global Aesthetic Improvement Scale (GAIS) |
66.6; 55.0; 47.0; 47.0; 72.2; 75.0 | — |
| SECONDARY Subject Assessment of Improvement Using Global Aesthetic Improvement Scale (GAIS) |
77.7; 55.0; 52.9; 52.9; 61.1; 84.2 | — |
| SECONDARY Subject Satisfaction With Treatment |
61.1; 55.0; 41.1; 58.8; 61.1; 78.9 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01853397). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.