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Evaluation of Procedural Analgesia for Liposonix Treatment

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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 )

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.

Condition or disease Intervention/treatment Phase
Body Contouring Device: Liposonix System (Model 2) Drug: Pre-treatment analgesia Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Evaluation of Procedural Analgesia for Out-Patient Liposonix Treatment
Study Start Date : November 2013
Actual Primary Completion Date : January 2014
Actual Study Completion Date : January 2014

Resource links provided by the National Library of Medicine


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)
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)




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. Safety Assessment [ Time Frame: Baseline, 1 day, 1 week ]
    Adverse events will be assessed and documented throughout the study

  2. 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).



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01993238


Locations
United States, California
Solta Medical Aesthetic Center
Hayward, California, United States, 94545
Sponsors and Collaborators
Solta Medical
Investigators
Principal Investigator: Ronald Wheeland, MD
Principal Investigator: Reid Rubsamen, MD

Responsible Party: Solta Medical
ClinicalTrials.gov Identifier: NCT01993238     History of Changes
Other Study ID Numbers: 13-140-LP-H
First Posted: November 25, 2013    Key Record Dates
Results First Posted: April 29, 2014
Last Update Posted: April 29, 2014
Last Verified: March 2014