Evaluation of Procedural Analgesia for Liposonix Treatment

Study Overview
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Brief Summary
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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.

Official Title
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An Evaluation of Procedural Analgesia for Out-Patient Liposonix Treatment

Conditions
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Body Contouring

Intervention / Treatment
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* Device: Liposonix System (Model 2)
* Drug: Pre-treatment analgesia


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Liposonix with pre-treatment analgesia<br>Liposonix System (Model 2) treatment of subcutaneous adipose tissue with pre-treatment analgesia (combination of ondansetron, ketorolac, and hydromorphone) | Device: Liposonix System (Model 2)<br>* Treatment of subcutaneous adipose tissue of the abdomen using high intensity focused ultrasound (Liposonix System Model 2).<br>Drug: Pre-treatment analgesia<br>* Pre-treatment analgesia (combination of ondansetron, ketorolac, and hydromorphone)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Score for Overall Treatment | 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) | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety Assessment | Adverse events will be assessed and documented throughout the study | Baseline, 1 day, 1 week | 
| Pain Scores Reported at 1-day Post-Treatment | 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). | 1 day |