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

NCT01853397 | Completed Results

• 1 other identifier: 13-137-LP-H
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (1)

• Change in Waist Circumference 12 Weeks After Treatment as Compared to Baseline

  Change from baseline in waist circumference 12 weeks after treatment was assessed by blinded evaluators.

  12 weeks

Secondary Outcomes (4)

• Change in Waist Circumference 4,8, and16 Weeks After Treatment as Compared to Baseline

  4 weeks, 8 weeks, 16 weeks

• Investigator Assessment of Improvement Using Global Aesthetic Improvement Scale (GAIS)

  4, 8, 12, and 16 weeks

• Subject Assessment of Improvement Using Global Aesthetic Improvement Scale (GAIS)

  4, 8, 12, and 16 weeks

• Subject Satisfaction With Treatment

  4, 8, 12, and 16 weeks

Study Arms (4)

Treatment at level 1

EXPERIMENTAL

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

Device: Liposonix System (Model 2)

Treatment at level 2

EXPERIMENTAL

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

Device: Liposonix System (Model 2)

Treatment at level 3

EXPERIMENTAL

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

Device: Liposonix System (Model 2)

Treatment with 3 passes at 60 J/cm2

ACTIVE COMPARATOR

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)

Interventions

Liposonix System (Model 2) DEVICE

Treatment at level 1; Treatment at level 2; Treatment at level 3; Treatment with 3 passes at 60 J/cm2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Solta Medical: lead

Study Sites (2)

Solta Medical Aesthetic Center

Hayward, California, 94545, United States

Location

Jewell Plastic Surgery Center

Eugene, Oregon, 97401, United States

Location

Results Point of Contact

• Title: Director of Clinical Programs
• Organization: Solta Medical

aloncaric@solta.com

510-259-5284

Study Officials

• Mark Jewell, MD

  Jewell Plastic Surgery Center

  PRINCIPAL INVESTIGATOR

• Ronald Wheeland, MD

  Solta Medical Aesthetic Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2013
• First Posted: May 15, 2013
• Study Start: April 1, 2013
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: April 16, 2015
• Results First Posted: March 27, 2015

Record last verified: 2015-03

Locations

US (2)