Evaluation of Procedural Analgesia for Liposonix Treatment

NCT ID: NCT01993238

Last Updated: 2014-04-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-11-30
• Study Completion Date: 2014-01-31

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.

Conditions

Body Contouring

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Liposonix with pre-treatment analgesia

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

Group Type: EXPERIMENTAL

Liposonix System (Model 2)

Intervention Type: DEVICE

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

Pre-treatment analgesia

Intervention Type: DRUG

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

Interventions

Liposonix System (Model 2)

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

Intervention Type: DEVICE

Pre-treatment analgesia

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

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Solta Medical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ronald Wheeland, MD

Role: PRINCIPAL_INVESTIGATOR

Reid Rubsamen, MD

Role: PRINCIPAL_INVESTIGATOR

Locations

Solta Medical Aesthetic Center

Hayward, California, United States

Countries

United States

Other Identifiers

13-140-LP-H

Identifier Type: -

Identifier Source: org_study_id