Evaluation of Procedural Analgesia for Liposonix Treatment

Launched by SOLTA MEDICAL · Nov 20, 2013

Keywords

ClinConnect Summary

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Gender

ALL

Eligibility criteria

• 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