UltraShape Power Device for Fat Reduction in Flanks

January 2, 2020 updated by: Syneron Medical

Clinical Assessment to Evaluate UltraShape Power Device Performance for Flanks Fat Reduction

Prospective, baseline-controlled evaluation of the UltraShape Power device for non-invasive fat reduction in flanks.

Study Overview

Status

Status

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Withdrawn

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.

Detailed Description

Eligible subjects will receive 3 bi-weekly treatments (2 weeks interval) with the UltraShape Power device according to the study protocol.

One random flank will be treated with one pass or remained as a control (no treatment) while the second flank will be treated with multiple passes.

Subjects will return for up to 4 follow up visits: 4 weeks, 8 weeks, 12 weeks and (optional) 24 weeks following end of treatment/s.

Each subject will be enrolled for total expected study duration of up to 28 weeks.

After last follow up visit, subjects who wish will receive compensation treatments (up to 3) on the flank who received regular treatment (single pass) or remained as a control (no treatment).

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

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

  • Israel
      • Tiberias, Israel
        • The Baruch Padeh Medical Center

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

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Signed informed consent to participate in the study.
  2. Female and male subjects, 18 and 65 years of age at the time of enrolment
  3. Fitzpatrick Skin Type I to VI.
  4. Fat thickness of at least 1.5 cm in the treated area (measured by calibrated caliper).
  5. BMI interval: 19 ≤ BMI ≤ 30 (normal to overweight, but not obese).
  6. If female, not pregnant, lactating and must be either post-menopausal, surgically sterilized, or using a medically acceptable form of birth control at least 3 months prior to enrollment (i.e., oral contraceptives, contraceptive implant, barrier methods with spermicide or abstinence).
  7. In addition, negative pregnancy inquiry as reviewed before each treatment and each follow up visit for women with bearing potential (e.g. not menopause).
  8. General good health confirmed by medical history and skin examination of the treated area.
  9. Willing to follow the treatment and follow-up schedule and post-treatment care instructions.
  10. Willingness to refrain from a change in diet/ exercise/medication regimen for the entire course of the study.
  11. Willing to have photographs and images taken of the treated areas to be used de-identified in evaluations, publications and presentations.

Exclusion Criteria:

  1. History of hypertension, ischemic heart disease, valvular heart disease, congestive heart failure, pacemaker/defibrillator, abdominal aortic aneurism
  2. Current hyperlipidemia, diabetes mellitus, hepatitis, liver disease, HIV positive status, blood coagulopathy or excessive bleeding, autoimmune or connective tissue disease
  3. Having or undergoing any form of treatment for active cancer, or having a history of skin cancer or any other cancer in the areas to be treated, including presence of malignant or pre-malignant pigmented lesions
  4. Having any active electrical implant anywhere in the body, such as a pacemaker or an internal defibrillator
  5. Having a permanent implant in the treated area, such as metal plates or an injected chemical substance such as silicone
  6. Having undergone any other surgery in the treated areas within 3 months of treatment or during the study, including liposuction
  7. Previous body contouring procedures in the treatment area within 12 months
  8. History of skin disease in the treatment area, known tendency to form keloids or poor wound healing
  9. Suffering from significant skin conditions in the treated areas or inflammatory skin conditions, including, but not limited to, open lacerations or abrasions and active cold sores prior to treatment (duration of resolution as per the Investigator's discretion) or during the treatment course
  10. Skin lesions in the treatment area other than simple nevi on physical examination (e.g., atypical nevus, tattoo, abrasions) including depressed scars in the treatment area
  11. Very poor skin quality (i.e., severe laxity)
  12. Abdominal wall diastasis or hernia on physical examination
  13. Abnormal kidney, liver or coagulation functions, abnormal lipid profile or blood count within the last 3 months
  14. Obesity (BMI > 30)
  15. Childbirth within the last 12 months or breastfeeding women. Any acute or chronic condition which, in the opinion of the investigator, could interfere with the conduct of the study
  16. Unstable weight within the last 6 months (i.e., ± 3% weight change in the prior six months)
  17. Inability to comply with fat measurement procedures (e.g., inability to hold breath for few seconds).
  18. Fat thickness lower than 1.5 cm before strapping at the treated area.
  19. Participation in another clinical study involving same anatomical areas within the last 6 months (or 30 days in case different anatomical areas were treated in previous trial/s).
  20. As per the Investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study.

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

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

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: One pass/no treatment arm
One random flank will be treated with UltraShape Power device with one pass or remained as a control (no treatment)
Device: UltraShape Power device

UltraShape Power is a non-invasive focused ultrasound device, approved by the FDA (160896K;170370K); CE; Israeli Ministry of Health. The UltraShape Power system works by emitting acoustic waves of focused ultrasonic energy (200 ± 30 KHz frequency) that converge into a confined focal volume underneath the skin, thereby, targeting only subcutaneous fat at a controlled depth. Unlike traditional ultrasound technology, UltraShape Power's energy transmits pulsed ultrasound, allowing control over temperature elevation. The system comprised of two main parts:

  • The Main console
  • Transducer
EXPERIMENTAL: Multiple passes treatment arm
Second flank will be treated with UltraShape Power device with multiple passes.
Device: UltraShape Power device

UltraShape Power is a non-invasive focused ultrasound device, approved by the FDA (160896K;170370K); CE; Israeli Ministry of Health. The UltraShape Power system works by emitting acoustic waves of focused ultrasonic energy (200 ± 30 KHz frequency) that converge into a confined focal volume underneath the skin, thereby, targeting only subcutaneous fat at a controlled depth. Unlike traditional ultrasound technology, UltraShape Power's energy transmits pulsed ultrasound, allowing control over temperature elevation. The system comprised of two main parts:

  • The Main console
  • Transducer

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
Measure Description
Time Frame
Fat Volume reduction
Time Frame: 12 weeks follow-up (12wk FU) versus baseline
MRI measurements for fat thickness in cc (cubic centimeter)
12 weeks follow-up (12wk FU) versus baseline
Treatment Safety as Assessed by Blood Lipid Level
Time Frame: up to 24 weeks
Verification similar of post-treatment and pre-treatment (baseline) blood lipid levels values [%]
up to 24 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
Measure Description
Time Frame
MRI Measurement of Fat Thickness Reduction
Time Frame: 4 weeks, 8 weeks, 12 weeks and (optional) 24 weeks versus baseline.
MRI measurements for Fat thickness in mm
4 weeks, 8 weeks, 12 weeks and (optional) 24 weeks versus baseline.
Ultrasound Measurement of Fat Thickness Reduction
Time Frame: 4 weeks, 8 weeks, 12 weeks and (optional) 24 weeks versus baseline.
Ultrasound measurements for Fat thickness in mm
4 weeks, 8 weeks, 12 weeks and (optional) 24 weeks versus baseline.
Fat Volume reduction
Time Frame: 4 weeks, 8 weeks and (optional) 24 weeks versus baseline.
MRI measurements for fat thickness in cc (cubic centimeter)
4 weeks, 8 weeks and (optional) 24 weeks versus baseline.

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.
Syneron Medical

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: Michael Jerdev, MD, The Baruch Padeh Medical Center

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 (ACTUAL)

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.
March 7, 2018

Primary Completion (ANTICIPATED)

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.
March 7, 2019

Study Completion (ANTICIPATED)

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.
September 7, 2019

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).
March 20, 2018

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 10, 2018

First Posted (ACTUAL)

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 18, 2018

Study Record Updates

Last Update Posted (ACTUAL)

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 6, 2020

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 2, 2020

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, 2020

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.
  • DHF24961

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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