Subcutaneous Contouring Using High Intensity Focused Ultrasound

NCT ID: NCT01104272

Last Updated: 2011-01-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-04-30
• Study Completion Date: 2011-01-31

Brief Summary

The device delivers High Intensity Focused Ultrasound (HIFU) energy that can disrupt subcutaneous adipose tissue (SAT) to provide a non-invasive approach to body sculpting, such as a reduction in waist circumference.

Conditions

Body Sculpting

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Blinding Strategy: NONE

Study Groups

Energy Level 1

Subcutaneous Adipose Tissue Treated With Energy Level 1.

Group Type: EXPERIMENTAL

LipoSonix (Ultrasound treatment of Subcutaneous Adipose Tissue)

Intervention Type: DEVICE

Study of Adipose Tissue Treatment Using Focused Ultrasound

Interventions

LipoSonix (Ultrasound treatment of Subcutaneous Adipose Tissue)

Study of Adipose Tissue Treatment Using Focused Ultrasound

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Male or female subjects, 18 to 65 years of age

2. Body Mass Index ≤30

3. Thickness of subcutaneous adipose tissue in the anticipated treatment area of ≥ 2.5 cm

4. Subjects must agree to not alter their normal and regular diet or exercise routines during the course of the study.

5. Subjects must be of African descent AND have Fitzpatrick skin types IV, V, or VI.

Exclusion Criteria

1. Female subject who is pregnant (i.e., has a positive urine pregnancy test), is suspected to be pregnant, or is lactating or becomes pregnant during the course of the study. (NOTE: Females of childbearing potential must have a negative urine pregnancy test prior to enrollment in the study.)

2. Subjects diagnosed with coagulation disorders or are receiving anticoagulant therapy or medications or dietary supplements which impede coagulation or platelet aggregation.

3. Subject has diabetes or cardiovascular disease.

4. Subject has had any aesthetic procedure to the region to be treated.

5. Subject has systemic skin disease or skin disease in the areas to be treated.

6. Subject has any abnormality of the skin or soft tissues of the abdominal wall in the areas to be treated.

7. Subject has had previous open or laparoscopic surgery in the anticipated treatment area.

8. Subjects is on prescription or over the counter weight reduction medication or programs, or had weight reduction procedures (e.g.: gastric bypass, Lap-Band, etc.)

9. Subject has skin or superficial tissue that does not lie flat on its own when the subject is in the supine position.

10. Subjects undergoing chronic steroid or immunosuppressive therapy.

11. Subjects who have cardiac pacemakers or any implantable electrical device, e.g. pacemaker, defibrillator, or neurostimulators.

12. Subjects who have metal implants of any type in the area to be treated.

13. History of cancer.

14. Subjects who have sensory loss or dysesthesia in the area to be treated.

15. Subject currently uses illicit drug(s) or abuses alcohol (defined as regular or daily consumption of more than 4 alcoholic drinks per day).

16. Subjects who cannot adhere to the study visit schedule (e.g., subjects not likely to stay in the study for a maximum of 27 weeks - screening through exit visit).

17. Subjects who are unable, or lack the capacity, to self consent.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medicis Technologies Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Medicis Technologies Corporation

Principal Investigators

Nowell Solish, MD

Role: PRINCIPAL_INVESTIGATOR

Dr. Nowell Solish Private Office

Sheetal Sapra, MD

Role: PRINCIPAL_INVESTIGATOR

Institute of Cosmetic and Laser Surgery

Locations

Institute of Cosmetic and Laser Surgery

Oakville, Ontario, Canada

Dr. Nowell Solish Private Office

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

LP-1100-05

Identifier Type: -

Identifier Source: org_study_id