Evaluation of Procedural Analgesia for Liposonix Treatment

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Liposonix with pre-treatment analgesia	Liposonix System (Model 2)	Liposonix System (Model 2) treatment of subcutaneous adipose tissue with pre-treatment analgesia (combination of ondansetron, ketorolac, and hydromorphone)
Liposonix with pre-treatment analgesia	Pre-treatment analgesia	Liposonix System (Model 2) treatment of subcutaneous adipose tissue with pre-treatment analgesia (combination of ondansetron, ketorolac, and hydromorphone)

Primary Outcome Measures

Name	Time	Method
Pain Score for Overall Treatment	Baseline	Following treatment, the subject was asked to evaluate the pain level for the overall treatment using the 0-10 Visual Analog Scale (0 represents no pain and 10 represents worst imaginable pain)

Secondary Outcome Measures

Name	Time	Method
Safety Assessment	Baseline, 1 day, 1 week	Adverse events will be assessed and documented throughout the study
Pain Scores Reported at 1-day Post-Treatment	1 day	During the 1-day follow-up phone call, subjects were asked to rate the pain they were currently experiencing from the Liposonix treatment using a 0-10 pain scale (0 represents no pain and 10 represents worst pain imaginable).