- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01993238
Evaluation of Procedural Analgesia for Liposonix Treatment
March 25, 2014 updated by: Solta Medical
An Evaluation of Procedural Analgesia for Out-Patient Liposonix Treatment
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
11
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Hayward, California, United States, 94545
- Solta Medical Aesthetic Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Liposonix with pre-treatment analgesia
Liposonix System (Model 2) treatment of subcutaneous adipose tissue with pre-treatment analgesia (combination of ondansetron, ketorolac, and hydromorphone)
|
Treatment of subcutaneous adipose tissue of the abdomen using high intensity focused ultrasound (Liposonix System Model 2).
Pre-treatment analgesia (combination of ondansetron, ketorolac, and hydromorphone)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
Baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety Assessment
Time Frame: Baseline, 1 day, 1 week
|
Adverse events will be assessed and documented throughout the study
|
Baseline, 1 day, 1 week
|
Pain Scores Reported at 1-day Post-Treatment
Time Frame: 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).
|
1 day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Ronald Wheeland, MD
- Principal Investigator: Reid Rubsamen, MD
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2013
Primary Completion (Actual)
January 1, 2014
Study Completion (Actual)
January 1, 2014
Study Registration Dates
First Submitted
November 11, 2013
First Submitted That Met QC Criteria
November 20, 2013
First Posted (Estimate)
November 25, 2013
Study Record Updates
Last Update Posted (Estimate)
April 29, 2014
Last Update Submitted That Met QC Criteria
March 25, 2014
Last Verified
March 1, 2014
More Information
Terms related to this study
Other Study ID Numbers
- 13-140-LP-H
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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