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Evaluation of Procedural Analgesia for Liposonix Treatment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01993238
Recruitment Status : Completed
First Posted : November 25, 2013
Results First Posted : April 29, 2014
Last Update Posted : April 29, 2014
Sponsor:
Information provided by (Responsible Party):
Valeant Pharmaceuticals ( Solta Medical )

Tracking Information
First Submitted Date  ICMJE November 11, 2013
First Posted Date  ICMJE November 25, 2013
Results First Submitted Date  ICMJE March 25, 2014
Results First Posted Date  ICMJE April 29, 2014
Last Update Posted Date April 29, 2014
Study Start Date  ICMJE November 2013
Actual Primary Completion Date January 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 25, 2014)
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)
Original Primary Outcome Measures  ICMJE
 (submitted: November 20, 2013)
Pain score [ Time Frame: Baseline ]
Pain levels recorded immediately post-treatment using Visual Analog Scale
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 25, 2014)
  • Safety Assessment [ Time Frame: Baseline, 1 day, 1 week ]
    Adverse events will be assessed and documented throughout the study
  • 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).
Original Secondary Outcome Measures  ICMJE
 (submitted: November 20, 2013)
  • Safety Assessment [ Time Frame: Baseline, 1 day, 1 week ]
    Adverse events will be assessed and documented throughout the study
  • Pain Score [ Time Frame: Baseline, 1 day ]
    Pain Scores reported during treatment and during 1 day follow-up using Numerical Rating Scale
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of Procedural Analgesia for Liposonix Treatment
Official Title  ICMJE An Evaluation of Procedural Analgesia for Out-Patient Liposonix Treatment
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Body Contouring
Intervention  ICMJE
  • 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)
Study Arms  ICMJE 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)
Interventions:
  • Device: Liposonix System (Model 2)
  • Drug: Pre-treatment analgesia
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 20, 2014)
11
Original Estimated Enrollment  ICMJE
 (submitted: November 20, 2013)
20
Actual Study Completion Date  ICMJE January 2014
Actual Primary Completion Date January 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01993238
Other Study ID Numbers  ICMJE 13-140-LP-H
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Valeant Pharmaceuticals ( Solta Medical )
Study Sponsor  ICMJE Solta Medical
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ronald Wheeland, MD
Principal Investigator: Reid Rubsamen, MD
PRS Account Valeant Pharmaceuticals
Verification Date March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP