UltraShape Power in Combination With U-sculpt-n Transducer

Clinical Evaluation of UltraShape Power System in Conjunction With the U-Sculpt-N Transducer for Non-invasive Circumference Reduction

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.

Study Overview

• Status: Unknown
• Conditions: Circumference Reduction
• Intervention / Treatment: Device: UltraShape Power

• Study Type: Interventional
• Enrollment (Anticipated): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Ramat Gan, Israel
    • Recruiting
    • Beit Noah
    • Contact: Ronen Glesinger, Dr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: single arm	Device: UltraShape Power; non-invasive body contouring procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Outer thigh circumference reduction	To evaluate circumference reduction of outer thigh post treatment with UltraShape Power device used with the U-Sculpt-N transducer versus control side.	up to 24 week
Treatment-related adverse events	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.	up to 24 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subject satisfaction questionnaire	The assessment of subject satisfaction with treatment will be recorded during relevant visits (starting following the first treatment) using a 5-point Likert scale	up to 24 week

Collaborators and Investigators

• Sponsor: Syneron Candela

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Anticipated): May 1, 2018
• Study Completion (Anticipated): October 1, 2018

Study Registration Dates

• First Submitted: October 30, 2016
• First Submitted That Met QC Criteria: November 3, 2016
• First Posted (Estimate): November 6, 2016

Study Record Updates

• Last Update Posted (Actual): August 1, 2017
• Last Update Submitted That Met QC Criteria: July 30, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: DHF21321