Effectiveness Study of the UltraShape® Contour I-Y for Non-Invasive Reduction in Abdominal Circumference

This study is not yet open for participant recruitment.
Verified May 2012 by UltraShape
Sponsor:
Information provided by (Responsible Party):
UltraShape
ClinicalTrials.gov Identifier:
NCT01609699
First received: May 29, 2012
Last updated: May 31, 2012
Last verified: May 2012

May 29, 2012
May 31, 2012
August 2012
December 2012   (final data collection date for primary outcome measure)
The primary objective of this study is to evaluate the efficacy of the Contour I - Y System on abdominal circumference reduction relative to baseline pretreatment values using different treatment methods. [ Time Frame: 3.5 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01609699 on ClinicalTrials.gov Archive Site
  • The secondary objective of this study subject satisfaction measured with a self-assessment questionnaire [ Time Frame: 3.5 months ] [ Designated as safety issue: No ]
  • Rate of device and procedure related adverse event adverse [ Time Frame: 3.5 months ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Effectiveness Study of the UltraShape® Contour I-Y for Non-Invasive Reduction in Abdominal Circumference
A Baseline Controlled Study to Evaluate the Effectiveness of the UltraShape® Contour I - Y System for Non-Invasive Reduction in Abdominal Circumference

The UltraShape® Contour I- Y system uses focused ultrasound to produce localized mechanical motion within fat tissues and cells for the purpose of producing mechanical cellular membrane disruption. It is intended for reduction in body circumference.

The primary objective of this study is to evaluate the efficacy of the Contour I - Y System on abdominal circumference reduction relative to baseline pretreatment values using different treatment methods.

The primary efficacy endpoint in this trial is Statistical Difference of Circumference reduction between Baseline measurement and at follow-up measurement.

Not Provided
Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Reduction in Abdominal Circumference
Device: Treatment with Contour I-Y system
The Contour I - Y System is a non-invasive focused ultrasound, for body contouring purposes, designed to selectively disrupt sub-dermal fat cells at a designated focus employing focused ultrasound. All other types of tissue, such as blood vessels, muscles and peripheral nerves remain intact. There are no thermal effects. Fat cell destruction is achieved by ultrasound-induced mechanical effects during a very short exposure time.
Other Name: UltraShape® Contour I - Y System
  • Experimental: Group A - will undergo 3 successive treatments, 1 week apart
    The Contour I - Y System is a non-invasive focused ultrasound, for body contouring purposes, designed to selectively disrupt sub-dermal fat cells at a designated focus employing focused ultrasound. All other types of tissue, such as blood vessels, muscles and peripheral nerves remain intact. There are no thermal effects. Fat cell destruction is achieved by ultrasound-induced mechanical effects during a very short exposure time.
    Intervention: Device: Treatment with Contour I-Y system
  • Experimental: Group B - will undergo 3 successive treatments, 2 weeks apart
    The Contour I - Y System is a non-invasive focused ultrasound, for body contouring purposes, designed to selectively disrupt sub-dermal fat cells at a designated focus employing focused ultrasound. All other types of tissue, such as blood vessels, muscles and peripheral nerves remain intact. There are no thermal effects. Fat cell destruction is achieved by ultrasound-induced mechanical effects during a very short exposure time.
    Interventions:
    • Device: Treatment with Contour I-Y system
    • Device: Treatment with Contour I-Y system
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
30
December 2012
December 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Female or male subjects, 18-65 years of age at the time of enrollment
  2. Abdominal and flank fat thickness of at least 1.5 cm prior to initial treatment (measurement by caliper)
  3. For women of child-bearing potential: negative pregnancy test in the 24 hour period prior to enrollment (measured in urine)
  4. General good health confirmed by medical history and skin examination of the treated area
  5. Written informed consent to participate in the study
  6. Ability to comply with the requirements of the study
  7. BMI ≤ 30

Exclusion Criteria:

  1. History of hypertension, ischemic heart disease, valvular heart disease, congestive heart failure, pacemaker/defibrillator, abdominal aortic aneurism
  2. Current hyperlipidemia, diabetes mellitus, hepatitis, liver disease, HIV positive status, blood coagulopathy or excessive bleeding, autoimmune or connective tissue disease or malignancy
  3. Previous liposuction in the treatment areas
  4. History of skin disease in the treatment area, known tendency to form keloids or poor wound healing
  5. Skin lesions in the treatment area other than simple nevi on physical examination (e.g., atypical nevus, tattoo, abrasions) including depressed scars in the treatment area
  6. Poor skin quality (i.e., laxity)
  7. Abdominal wall diastasis or hernia on physical examination
  8. Abnormal kidney, liver or coagulation functions, abnormal lipid profile or blood count within the last 3 months
  9. Obesity (BMI > 30)
  10. Childbirth within the last 12 months or women who suckling a child
  11. Any acute or chronic condition which, in the opinion of the Investigator, could interfere with the conduct of the study
  12. Unstable weight within the last 6 months (i.e., ± 3% weight change in the prior six months)
  13. Inability to comply with circumference measurement procedure (e.g., inability to held breath for the required duration)
  14. Participation in another clinical study
  15. Previous body contouring treatments in the abdomen or love handle areas
Both
18 Years to 65 Years
Yes
Contact: Lior Greenbaum, PhD +972.4.909.4418 lior@ultrashape.com
Israel
 
NCT01609699
US-RB-CY1
No
UltraShape
UltraShape
Not Provided
Principal Investigator: Dean Ad-El, MD Rabin Medical Center - Beilinson Hospital
UltraShape
May 2012

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