An Evaluation of Procedural Analgesia for Out-Patient Liposonix Treatment
Overview
- Phase
- N/A
- Intervention
- Liposonix System (Model 2)
- Conditions
- Body Contouring
- Sponsor
- Solta Medical
- Enrollment
- 11
- Locations
- 1
- Primary Endpoint
- Pain Score for Overall Treatment
- Status
- Completed
- Last Updated
- 12 years ago
Overview
Brief Summary
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.
Investigators
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/m
- •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
Arms & Interventions
Liposonix with pre-treatment analgesia
Liposonix System (Model 2) treatment of subcutaneous adipose tissue with pre-treatment analgesia (combination of ondansetron, ketorolac, and hydromorphone)
Intervention: Liposonix System (Model 2)
Liposonix with pre-treatment analgesia
Liposonix System (Model 2) treatment of subcutaneous adipose tissue with pre-treatment analgesia (combination of ondansetron, ketorolac, and hydromorphone)
Intervention: Pre-treatment analgesia
Outcomes
Primary Outcomes
Pain Score for Overall Treatment
Time Frame: 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 Outcomes
- Safety Assessment(Baseline, 1 day, 1 week)
- Pain Scores Reported at 1-day Post-Treatment(1 day)