UltraShape Power in Combination With U-sculpt-n Transducer

Not Applicable

• Conditions: Circumference Reduction
• Interventions: Device: UltraShape Power

• Registration Number: NCT02956720
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-10-30
• Study First Submitted QC: 2016-11-03
• Study First Posted: 2016-11-06
• Study Start: 2017-01
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-30
• Last Update Posted: 2017-08-01
• Primary Completion: 2018-05
• Study Completion: 2018-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 24

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
single arm	UltraShape Power	-

Primary Outcome Measures

Name	Time	Method
Outer thigh circumference reduction	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	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

Name	Time	Method
Subject satisfaction questionnaire	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

Trial Locations

Locations (1)

Beit Noah; 🇮🇱 Ramat Gan, Israel