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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
History of Changes
  Purpose

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.


Condition Intervention
Reduction in Abdominal Circumference
 Device: Treatment with Contour I-Y system

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Baseline Controlled Study to Evaluate the Effectiveness of the UltraShape® Contour I - Y System for Non-Invasive Reduction in Abdominal Circumference

Further study details as provided by UltraShape:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 30
Study Start Date: August 2012
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
 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 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.
 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
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01609699

Contacts
Contact: Lior Greenbaum, PhD +972.4.909.4418 lior@ultrashape.com

Locations
Israel
Rabin Medical Center - Beilinson Hospital Not yet recruiting
Petah Tikva, Israel, 4941492
Principal Investigator: Dean Ad-El, MD            
Sponsors and Collaborators
UltraShape
Investigators
Principal Investigator: Dean Ad-El, MD Rabin Medical Center - Beilinson Hospital
  More Information

No publications provided

Responsible Party: UltraShape
ClinicalTrials.gov Identifier: NCT01609699     History of Changes
Other Study ID Numbers: US-RB-CY1
Study First Received: May 29, 2012
Last Updated: May 31, 2012
Health Authority: Israel: Ministry of Health

Keywords provided by UltraShape:
body circumference
Non-Invasive Reduction

ClinicalTrials.gov processed this record on June 18, 2013