Body Contouring
Conditions
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.
Interventions
Treatment of subcutaneous adipose tissue of the abdomen using high intensity focused ultrasound (Liposonix System Model 2).
DRUGPre-treatment analgesia
Pre-treatment analgesia (combination of ondansetron, ketorolac, and hydromorphone)
Sponsors
Solta Medical
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Liposonix With Pre-treatment Analgesia Liposonix System (Model 2) treatment of subcutaneous adipose tissue with pre-treatment analgesia (combination of ondansetron, ketorolac, and hydromorphone)
Liposonix System (Model 2): Treatment of subcutaneous adipose tissue of the abdomen using high intensity focused ultrasound (Liposonix System Model 2).
Pre-treatment analgesia: Pre-treatment analgesia (combination of ondansetron, ketorolac, and hydromorphone) | 11 |
| Total | 11 |
Baseline characteristics
| Characteristic | Liposonix With Pre-treatment Analgesia |
|---|---|
| Age, Continuous | 35.9 years STANDARD_DEVIATION 11.2 |
| Region of Enrollment United States | 11 participants |
| Sex: Female, Male Female | 9 Participants |
| Sex: Female, Male Male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 11 / 11 |
| serious Total, serious adverse events | 1 / 11 |
Outcome results
Primary
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)
Time frame: Baseline
Population: Intent to Treat
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Liposonix With Pre-treatment Analgesia | Pain Score for Overall Treatment | 6.3 units on a scale | Standard Deviation 2.2 |
Secondary
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).
Time frame: 1 day
Population: Intent-to-Treat
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Liposonix With Pre-treatment Analgesia | Pain Scores Reported at 1-day Post-Treatment | 2.1 units on a scale | Standard Deviation 2.6 |
Secondary
Safety Assessment
Adverse events will be assessed and documented throughout the study
Time frame: Baseline, 1 day, 1 week