Clinical trial NCT01609699: Effectiveness Study of the UltraShape® Contour I-Y for Non-Invasive Reduction in Abdominal Circumference
Official title: A Baseline Controlled Study to Evaluate the Effectiveness of the UltraShape® Contour I - Y System for Non-Invasive Reduction in Abdominal Circumference
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Reduction in Abdominal Circumference
Keywords: body circumference
Non-Invasive Reduction
Lead sponsor: UltraShape
Sponsor class: INDUSTRY
First posted: 2012-06-01
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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

Primary outcomes:
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.
timeFrame: 3.5 months
Secondary outcomes:
measure: The secondary objective of this study subject satisfaction measured with a self-assessment questionnaire
timeFrame: 3.5 months
measure: Rate of device and procedure related adverse event adverse
timeFrame: 3.5 months
Other outcomes:
Locations:
city: Petah Tikva
country: Israel
facility: Rabin Medical Center - Beilinson Hospital
Study officials:
affiliation: Rabin Medical Center - Beilinson Hospital
name: Dean Ad-El, MD
role: PRINCIPAL_INVESTIGATOR
References: