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

NCT ID: NCT01853397

Last Updated: 2015-04-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-04-30
• Study Completion Date: 2014-02-28

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.

Conditions

Subcutaneous Adipose Tissue

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Treatment at level 1

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

Group Type: EXPERIMENTAL

Liposonix System (Model 2)

Intervention Type: DEVICE

Treatment at level 2

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

Group Type: EXPERIMENTAL

Liposonix System (Model 2)

Intervention Type: DEVICE

Treatment at level 3

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

Group Type: EXPERIMENTAL

Liposonix System (Model 2)

Intervention Type: DEVICE

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)

Group Type: ACTIVE_COMPARATOR

Liposonix System (Model 2)

Intervention Type: DEVICE

Interventions

Liposonix System (Model 2)

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Solta Medical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mark Jewell, MD

Role: PRINCIPAL_INVESTIGATOR

Jewell Plastic Surgery Center

Ronald Wheeland, MD

Role: PRINCIPAL_INVESTIGATOR

Solta Medical Aesthetic Center

Locations

Solta Medical Aesthetic Center

Hayward, California, United States

Jewell Plastic Surgery Center

Eugene, Oregon, United States

Countries

United States

Other Identifiers

13-137-LP-H

Identifier Type: -

Identifier Source: org_study_id