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

Solta Medical

Status: Completed

Conditions: Subcutaneous Adipose Tissue

Treatments: Device: Liposonix System (Model 2)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01853397

13-137-LP-H

Details and patient eligibility

About

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.

Enrollment: 72 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

72 participants in 4 patient groups

Treatment at level 1

Experimental group

Description:

Single treatment with Liposonix System (Model 2) using single pass technique at level 1 (180 J/cm2)

Treatment:

Device: Liposonix System (Model 2)

Treatment at level 2

Experimental group

Description:

Single treatment with Liposonix System (Model 2)using the single pass technique at treatment level 2 (140 J/cm2)

Treatment:

Device: Liposonix System (Model 2)

Treatment at level 3

Experimental group

Description:

Single treatment with Liposonix System (Model 2)using single pass technique at level 3 (120 J/cm2)

Treatment:

Device: Liposonix System (Model 2)

Treatment with 3 passes at 60 J/cm2

Active Comparator group

Description:

Single treatment with Liposonix System (Model 2) using grid repeat technique with 3 passes at 60 J/cm2 (180 J/cm2 total fluence)

Treatment:

Device: Liposonix System (Model 2)