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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

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.

Condition or disease Intervention/treatment Phase
Circumference Reduction Device: UltraShape Power Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Intervention Model: Single Group Assignment
Intervention Model Description: prospective, single arm
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Evaluation of UltraShape Power System in Conjunction With the U-Sculpt-N Transducer for Non-invasive Circumference Reduction
Actual Study Start Date : January 2017
Estimated Primary Completion Date : May 2018
Estimated Study Completion Date : October 2018

Arm Intervention/treatment
Experimental: single arm Device: UltraShape Power
non-invasive body contouring procedure




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02956720


Contacts
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Contact: Ketty Shkolnik, Ph.D. +972-73-2442268 kettys@syneron-candela.com

Locations
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Israel
Beit Noah Recruiting
Ramat Gan, Israel
Contact: Ronen Glesinger, Dr         
Sponsors and Collaborators
Syneron Candela

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Responsible Party: Ronen Glesinger, Principal investigator, Syneron Candela
ClinicalTrials.gov Identifier: NCT02956720     History of Changes
Other Study ID Numbers: DHF21321
First Posted: November 7, 2016    Key Record Dates
Last Update Posted: August 1, 2017
Last Verified: July 2017