Skip to main content
OpenTrials
Completed

NCT Number: NCT01853397

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Subcutaneous Adipose Tissue

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Solta Medical Aesthetic Center, Hayward, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Liposonix System (Model 2)

Device

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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'.

  3. 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. 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').

Sponsors and collaborators

Lead sponsor

Solta Medical

Industry

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
May 15, 2013
Registry last updated
Apr 16, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.