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

NCT ID: NCT01609699

Last Updated: 2012-06-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-08-31
• Study Completion Date: 2012-12-31

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.

Conditions

Reduction in Abdominal Circumference

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Treatment with Contour I-Y system

Intervention Type: DEVICE

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.

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.

Group Type: EXPERIMENTAL

Treatment with Contour I-Y system

Intervention Type: DEVICE

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.

Treatment with Contour I-Y system

Intervention Type: DEVICE

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

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.

Intervention Type: 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.

Intervention Type: DEVICE

Other Intervention Names

UltraShape® Contour I - Y System; UltraShape® Contour I - Y System

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

UltraShape

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dean Ad-El, MD

Role: PRINCIPAL_INVESTIGATOR

Rabin Medical Center - Beilinson Hospital

Locations

Rabin Medical Center - Beilinson Hospital

Petah Tikva, , Israel

Countries

Israel

Central Contacts

Lior Greenbaum, PhD

Role: CONTACT

lior@ultrashape.com

+972.4.909.4418

Other Identifiers

US-RB-CY1

Identifier Type: -

Identifier Source: org_study_id