NCT01823653

Brief Summary

The purpose of this study is to assess the safety and efficacy of treatment with the Liposonix System (Model 2) for the circumferential reduction of subcutaneous adipose tissue (SAT) of the thighs.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2012

Shorter than P25 for not_applicable

Geographic Reach
2 countries

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2012

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 29, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 4, 2013

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

April 29, 2014

Completed
Last Updated

December 31, 2014

Status Verified

December 1, 2014

Enrollment Period

6 months

First QC Date

March 29, 2013

Results QC Date

March 25, 2014

Last Update Submit

December 10, 2014

Conditions

Treatment of Adipose Tissue in the Thighs

Outcome Measures

Primary Outcomes (1)

  • Clinical Improvement in Thigh Circumference

    Clinical improvement measured by change from baseline thigh circumference after treatment

    12 weeks (minus baseline)

Secondary Outcomes (5)

  • Percentage of Participants Showing Clinical Improvement Using the Global Aesthetic Improvement Scale (GAIS) Post Treatment, Assessed by Investigator

    12 weeks

  • Patient Satisfaction Using 1-5 Likert Scale

    12 weeks

  • Safety Assessment

    1, 4, 8, 12 weeks

  • Subcutaneous Adipose Thickness

    12 weeks

  • Global Aesthetic Improvement Scale (GAIS) Score Post Treatment Assessed by Investigator for Determining Clinical Improvement

    12 weeks

Study Arms (1)

Treated Thigh

EXPERIMENTAL

Subjects randomly received treatment of either the left or right thigh with the Liposonix System (Model 2)

Device: Liposonix System (Model 2)

Interventions

Liposonix System (Model 2)DEVICE

Treatment of Subcutaneous Adipose Tissue in the thighs using High Intensity Focused Ultrasound

Treated Thigh

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Male or female subjects between 18-60 years of age
  • Body Mass Index of ≤30 lb/in2
  • Thickness of adipose tissue is at least 1.0 cm beyond the selected focal depth in the area to be treated (≥2.3cm)
  • Subjects must agree not to alter their regular diet or exercise routines during the course of the study
  • Subjects must be willing and able to comply with all study visit requirements, procedures, and assessments
  • Subject must understand the nature of the study and sign an IRB approved Informed Consent

You may not qualify if:

  • Subjects is pregnant
  • Subjects diagnosed with a coagulation disorder or receiving anticoagulant therapy
  • Subject has had prior aesthetic procedures in the area to be treated
  • Subjects has pacemaker, defibrillator, or other implantable electrical device
  • Subject has significant circumferential asymmetry between thighs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Van Dyke Laser and Skin

Paradise Valley, Arizona, 85253, United States

Location

Solta Medical Aesthetic Center

Hayward, California, 94545, United States

Location

Jewell Plastic Surgery Center

Eugene, Oregon, 97401, United States

Location

Solish M.D.

Toronto, Ontario, Canada

Location

Results Point of Contact

Title
Director of Clinical Programs
Organization
Solta Medical
aloncaric@solta.com
510-259-5284

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 29, 2013

First Posted

April 4, 2013

Study Start

July 1, 2012

Primary Completion

January 1, 2013

Study Completion

January 1, 2013

Last Updated

December 31, 2014

Results First Posted

April 29, 2014

Record last verified: 2014-12

Locations

US(3)CA(1)