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UltraShape Power in Combination With U-sculpt-n Transducer

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ClinicalTrials.gov Identifier: NCT02956720
Recruitment Status : Unknown
Verified July 2017 by Ronen Glesinger, Syneron Candela.
Recruitment status was:  Recruiting
First Posted : November 7, 2016
Last Update Posted : August 1, 2017
Sponsor:
Information provided by (Responsible Party):
Ronen Glesinger, Syneron Candela

Tracking Information
First Submitted Date  ICMJE October 30, 2016
First Posted Date  ICMJE November 7, 2016
Last Update Posted Date August 1, 2017
Actual Study Start Date  ICMJE January 2017
Estimated Primary Completion Date May 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 30, 2017)
  • Outer thigh circumference reduction [ Time Frame: up to 24 week ]
    To evaluate circumference reduction of outer thigh post treatment with UltraShape Power device used with the U-Sculpt-N transducer versus control side.
  • Treatment-related adverse events [ Time Frame: up to 24 week ]
    The frequency and severity of all treatment-related adverse events during and after using the UltraShape Power device used with the U-Sculpt-N transducer.
Original Primary Outcome Measures  ICMJE
 (submitted: November 3, 2016)
  • Outer thigh and/or flank circumference reduction [ Time Frame: up to 22 week ]
    To evaluate circumference reduction of outer thigh and/or flank post treatment with UltraShape Power device used with the U-Sculpt-N transducer versus control side.
  • Treatment-related adverse events [ Time Frame: up to 22 week ]
    The frequency and severity of all treatment-related adverse events during and after using the UltraShape Power device used with the U-Sculpt-N transducer.
Change History Complete list of historical versions of study NCT02956720 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 30, 2017)
Subject satisfaction questionnaire [ Time Frame: up to 24 week ]
The assessment of subject satisfaction with treatment will be recorded during relevant visits (starting following the first treatment) using a 5-point Likert scale
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE UltraShape Power in Combination With U-sculpt-n Transducer
Official Title  ICMJE Clinical Evaluation of UltraShape Power System in Conjunction With the U-Sculpt-N Transducer for Non-invasive Circumference Reduction
Brief Summary Prospective, open label, self - controlled, single arm, clinical study to assess the performance of the UltraShape Power using the U-Sculpt-N on outer thigh and/or flank for circumference reduction versus self-control.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Intervention Model Description:
prospective, single arm
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Circumference Reduction
Intervention  ICMJE Device: UltraShape Power
non-invasive body contouring procedure
Study Arms  ICMJE Experimental: single arm
Intervention: Device: UltraShape Power
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: November 3, 2016)
24
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2018
Estimated Primary Completion Date May 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Subject ≥18 and ≤60 years of age at the time of enrollment
  2. Fat thickness of at least 1.5 cm in the outer thigh and/or flank (measured by calibrated caliper)
  3. For women of child-bearing potential: negative urine pregnancy test
  4. General good health confirmed by medical history and skin examination of the treated area
  5. Subject understands the study requirements and the treatment procedures and provides written Informed Consent before any study-specific tests or procedures are performed.

Exclusion Criteria:

  1. History of un-balanced hypertension, ischemic heart disease, valvular heart disease, congestive heart failure, pacemaker/defibrillator
  2. Current hyperlipidemia, diabetes mellitus, hepatitis, liver disease, HIV positive status, blood coagulopathy or excessive bleeding, autoimmune or connective tissue disease
  3. Having a permanent implant in the treated area, such as metal plates, or an injected chemical substance such as silicone
  4. Previous liposuction in the treatment areas within 12 months
  5. History of skin disease in the treatment area, known tendency to form keloids or poor wound healing
  6. Abnormal kidney, liver or coagulation functions, abnormal lipid profile or blood count within the last 3 months
  7. Childbirth within the last 12 months or women who are breastfeeding a child
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02956720
Other Study ID Numbers  ICMJE DHF21321
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ronen Glesinger, Syneron Candela
Study Sponsor  ICMJE Syneron Candela
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Syneron Candela
Verification Date July 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP