Evaluation of Procedural Analgesia for Liposonix Treatment

An Evaluation of Procedural Analgesia for Out-Patient Liposonix Treatment

The objectives of this study are to evaluate the safety and effectiveness of procedural analgesia for improvements in tolerability of treatment with the Liposonix System.

Inclusion Criteria:

• Subject is an adult female or male, 18 to 65 years of age.
• Subject must weigh more than 120 pounds.
• Subject must have a Body Mass Index of ≤ 30 kg/m2.
• Subject must have thickness of skin + subcutaneous adipose tissue in the anticipated treatment area of ≥ 2.3 cm.
• Subject must be able to read, write, speak, and understand English.

Exclusion Criteria:

• Female subject who is pregnant, is suspected to be pregnant, or is lactating
• Subjects diagnosed with coagulation disorders or are receiving anticoagulant therapy or medications or dietary supplements which impede coagulation or platelet aggregation
• Subject has diabetes or cardiovascular disease
• Subject has had any aesthetic procedure to the region to be treated within past 6 months
• Subject has systemic skin disease or skin disease in the area to be treated
• Subject has any abnormality of the skin or soft tissues of the abdominal wall in the area to be treated
• Subject has had previous open or laparoscopic surgery in the anticipated treatment area
• Subjects is on prescription or over the counter weight reduction medication or programs, or had weight reduction procedures
• Subject has skin or superficial tissue that does not lie flat on its own when the subject is in the supine position
• Subjects undergoing chronic steroid or immunosuppressive therapy
• Subjects who have cardiac pacemakers or any implantable electrical device
• Subjects who have metal implants of any type in the area to be treated
• History of cancer
• Subjects who have sensory loss or dysesthesia in the area to be treated
• Subjects taking chronic benzodiazepines or opiates
• Subjects with a history of severe nausea/vomiting with opioid analgesics
• Subjects with sleep apnea
• Subjects with known allergies or sensitivities to study drugs
• Subjects with liver disease
• Subjects with renal failure