Subcutaneous Contouring Using High Intensity Focused Ultrasound

January 17, 2011 updated by: Medicis Technologies Corporation

An Evaluation of the Treatment of Adipose Tissue Using a Focused Ultrasound Device in Subjects With Fitzpatrick IV-VI Skin Types

The device delivers High Intensity Focused Ultrasound (HIFU) energy that can disrupt subcutaneous adipose tissue (SAT) to provide a non-invasive approach to body sculpting, such as a reduction in waist circumference.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
36

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Oakville, Ontario, Canada, L6J7W5
        • Institute of Cosmetic and Laser Surgery
      • Toronto, Ontario, Canada, M5R3N8
        • Dr. Nowell Solish Private Office

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

All of the following inclusion criteria must be met at the time of screening before the subject is enrolled into the study:

  1. Male or female subjects, 18 to 65 years of age
  2. Body Mass Index ≤30
  3. Thickness of subcutaneous adipose tissue in the anticipated treatment area of ≥ 2.5 cm
  4. Subjects must agree to not alter their normal and regular diet or exercise routines during the course of the study.
  5. Subjects must be of African descent AND have Fitzpatrick skin types IV, V, or VI.

Exclusion Criteria:

A subject is ineligible to participate in this study if they meet any of the following exclusion criteria at screening:

  1. Female subject who is pregnant (i.e., has a positive urine pregnancy test), is suspected to be pregnant, or is lactating or becomes pregnant during the course of the study. (NOTE: Females of childbearing potential must have a negative urine pregnancy test prior to enrollment in the study.)
  2. Subjects diagnosed with coagulation disorders or are receiving anticoagulant therapy or medications or dietary supplements which impede coagulation or platelet aggregation.
  3. Subject has diabetes or cardiovascular disease.
  4. Subject has had any aesthetic procedure to the region to be treated.
  5. Subject has systemic skin disease or skin disease in the areas to be treated.
  6. Subject has any abnormality of the skin or soft tissues of the abdominal wall in the areas to be treated.
  7. Subject has had previous open or laparoscopic surgery in the anticipated treatment area.
  8. Subjects is on prescription or over the counter weight reduction medication or programs, or had weight reduction procedures (e.g.: gastric bypass, Lap-Band, etc.)
  9. Subject has skin or superficial tissue that does not lie flat on its own when the subject is in the supine position.
  10. Subjects undergoing chronic steroid or immunosuppressive therapy.
  11. Subjects who have cardiac pacemakers or any implantable electrical device, e.g. pacemaker, defibrillator, or neurostimulators.
  12. Subjects who have metal implants of any type in the area to be treated.
  13. History of cancer.
  14. Subjects who have sensory loss or dysesthesia in the area to be treated.
  15. Subject currently uses illicit drug(s) or abuses alcohol (defined as regular or daily consumption of more than 4 alcoholic drinks per day).
  16. Subjects who cannot adhere to the study visit schedule (e.g., subjects not likely to stay in the study for a maximum of 27 weeks - screening through exit visit).
  17. Subjects who are unable, or lack the capacity, to self consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Energy Level 1
Subcutaneous Adipose Tissue Treated With Energy Level 1.
Device: LipoSonix (Ultrasound treatment of Subcutaneous Adipose Tissue)
Study of Adipose Tissue Treatment Using Focused Ultrasound

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Change from baseline in waist circumference
Time Frame: 12 weeks
12 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
The change from Baseline in waist circumference measured after treatment, for the average of the two waist circumference measurements at the iliac crest as well as for each of the individual measurements.
Time Frame: 4 weeks
4 weeks
The change from Baseline in waist circumference measured after treatment, for the average of the two waist circumference measurements at the iliac crest as well as for each of the individual measurements.
Time Frame: 8 weeks
8 weeks
Patient satisfaction as recorded on the Subject Satisfaction Survey after treatment.
Time Frame: 1 week
1 week
Patient satisfaction as recorded on the Subject Satisfaction Survey after treatment.
Time Frame: 4 weeks
4 weeks
Patient satisfaction as recorded on the Subject Satisfaction Survey after treatment.
Time Frame: 8 weeks
8 weeks
Patient satisfaction as recorded on the Subject Satisfaction Survey after treatment.
Time Frame: 12 weeks
12 weeks
Visual Analog Scale (VAS) diary to record post treatment discomfort.
Time Frame: 1 week
1 week
Improvement as determined by a Global Aesthetic Improvement Scale (GAIS) score of 'improved' or 'much improved' at each post-baseline visit, as assessed by the Investigator.
Time Frame: 1 week
1 week
Improvement as determined by a Global Aesthetic Improvement Scale (GAIS) score of 'improved' or 'much improved' at each post-baseline visit, as assessed by the Investigator.
Time Frame: 4 weeks
4 weeks
Improvement as determined by a Global Aesthetic Improvement Scale (GAIS) score of 'improved' or 'much improved' at each post-baseline visit, as assessed by the Investigator.
Time Frame: 8 weeks
8 weeks
Improvement as determined by a Global Aesthetic Improvement Scale (GAIS) score of 'improved' or 'much improved' at each post-baseline visit, as assessed by the Investigator.
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Medicis Technologies Corporation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Nowell Solish, MD, Dr. Nowell Solish Private Office
  • Principal Investigator: Sheetal Sapra, MD, Institute of Cosmetic and Laser Surgery

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2011

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2011

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 9, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 14, 2010

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 15, 2010

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 19, 2011

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 17, 2011

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2011

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • LP-1100-05

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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