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
1 other identifier
interventional
24
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 30, 2016
CompletedFirst Posted
Study publicly available on registry
November 7, 2016
CompletedStudy Start
First participant enrolled
January 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2018
CompletedAugust 1, 2017
July 1, 2017
1.3 years
October 30, 2016
July 30, 2017
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (1)
Subject satisfaction questionnaire
up to 24 week
Study Arms (1)
single arm
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Subject ≥18 and ≤60 years of age at the time of enrollment
- Fat thickness of at least 1.5 cm in the outer thigh and/or flank (measured by calibrated caliper)
- For women of child-bearing potential: negative urine pregnancy test
- General good health confirmed by medical history and skin examination of the treated area
- Subject understands the study requirements and the treatment procedures and provides written Informed Consent before any study-specific tests or procedures are performed.
You may not qualify if:
- History of un-balanced hypertension, ischemic heart disease, valvular heart disease, congestive heart failure, pacemaker/defibrillator
- Current hyperlipidemia, diabetes mellitus, hepatitis, liver disease, HIV positive status, blood coagulopathy or excessive bleeding, autoimmune or connective tissue disease
- Having a permanent implant in the treated area, such as metal plates, or an injected chemical substance such as silicone
- Previous liposuction in the treatment areas within 12 months
- History of skin disease in the treatment area, known tendency to form keloids or poor wound healing
- Abnormal kidney, liver or coagulation functions, abnormal lipid profile or blood count within the last 3 months
- Childbirth within the last 12 months or women who are breastfeeding a child
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Syneron Candelalead
Study Sites (1)
Beit Noah
Ramat Gan, Israel
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal investigator
Study Record Dates
First Submitted
October 30, 2016
First Posted
November 7, 2016
Study Start
January 1, 2017
Primary Completion
May 1, 2018
Study Completion
October 1, 2018
Last Updated
August 1, 2017
Record last verified: 2017-07