Evaluation of Procedural Analgesia for Liposonix Treatment

Solta Medical

Status: Completed

Conditions: Body Contouring

Treatments: Drug: Pre-treatment analgesia; Device: Liposonix System (Model 2)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01993238

13-140-LP-H

Details and patient eligibility

About

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.

Enrollment: 11 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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11 participants in 1 patient group

Liposonix with pre-treatment analgesia

Experimental group

Description:

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

Treatment:

Device: Liposonix System (Model 2)

Drug: Pre-treatment analgesia