Evaluation of Procedural Analgesia for Liposonix Treatment

Body Contouring Clinical Trial

Official title:

An Evaluation of Procedural Analgesia for Out-Patient Liposonix Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01993238
• Other study ID #: 13-140-LP-H
• Status: Completed
• Phase: N/A
• First received: November 11, 2013
• Last updated: March 25, 2014
• Start date: November 2013
• Est. completion date: January 2014

Study information

• Verified date: March 2014
• Source: Valeant Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Body Contouring

Intervention

Device:
• Liposonix System (Model 2)
Treatment of subcutaneous adipose tissue of the abdomen using high intensity focused ultrasound (Liposonix System Model 2).

Drug:
• Pre-treatment analgesia
Pre-treatment analgesia (combination of ondansetron, ketorolac, and hydromorphone)

Locations

Country	Name	City	State
United States	Solta Medical Aesthetic Center	Hayward	California

Sponsors (1)

Lead Sponsor	Collaborator
Solta Medical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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)	Baseline	No
Secondary	Safety Assessment	Adverse events will be assessed and documented throughout the study	Baseline, 1 day, 1 week	Yes
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).	1 day	No