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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 )

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Body Contouring
Interventions Device: Liposonix System (Model 2)
Drug: Pre-treatment analgesia
Enrollment 11
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Liposonix With Pre-treatment Analgesia
Hide Arm/Group Description

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

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

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

Period Title: Overall Study
Started 11
Completed 11
Not Completed 0
Arm/Group Title Liposonix With Pre-treatment Analgesia
Hide Arm/Group Description

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

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

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

Overall Number of Baseline Participants 11
Hide Baseline Analysis Population Description
Intent-to-Treat
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 11 participants
35.9  (11.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants
Female
9
  81.8%
Male
2
  18.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 11 participants
11
1.Primary Outcome
Title Pain Score for Overall Treatment
Hide Description 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)
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat
Arm/Group Title Liposonix With Pre-treatment Analgesia
Hide Arm/Group Description:

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

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

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

Overall Number of Participants Analyzed 11
Mean (Standard Deviation)
Unit of Measure: units on a scale
6.3  (2.2)
2.Secondary Outcome
Title Safety Assessment
Hide Description Adverse events will be assessed and documented throughout the study
Time Frame Baseline, 1 day, 1 week
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Pain Scores Reported at 1-day Post-Treatment
Hide Description 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).
Time Frame 1 day
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat
Arm/Group Title Liposonix With Pre-treatment Analgesia
Hide Arm/Group Description:

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

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

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

Overall Number of Participants Analyzed 11
Mean (Standard Deviation)
Unit of Measure: units on a scale
2.1  (2.6)
Time Frame Adverse event data were collected from day 0 through study follow-up (1 week post-treatment)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Liposonix With Pre-treatment Analgesia
Hide Arm/Group Description

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

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

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

All-Cause Mortality
Liposonix With Pre-treatment Analgesia
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
Liposonix With Pre-treatment Analgesia
Affected / at Risk (%) # Events
Total   1/11 (9.09%)    
Musculoskeletal and connective tissue disorders   
Car Accident * [1]  1/11 (9.09%)  1
*
Indicates events were collected by non-systematic assessment
[1]
Patient admitted to hospital following car accident for lower back pain. Unrelated to treatment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Liposonix With Pre-treatment Analgesia
Affected / at Risk (%) # Events
Total   11/11 (100.00%)    
General disorders   
Pain during treatment *  11/11 (100.00%)  11
Nausea/Vomiting *  3/11 (27.27%)  3
Dizziness/Feeling Faint *  2/11 (18.18%)  2
Tiredness *  1/11 (9.09%)  1
Headache *  2/11 (18.18%)  2
Feeling cold *  1/11 (9.09%)  1
Pain with movement *  1/11 (9.09%)  1
Sense of pressure at treatment site *  1/11 (9.09%)  1
Flu-like symptoms *  1/11 (9.09%)  1
Skin and subcutaneous tissue disorders   
Ecchymosis *  10/11 (90.91%)  10
Erythema *  11/11 (100.00%)  11
Tenderness *  5/11 (45.45%)  5
Soreness *  5/11 (45.45%)  5
Tingling/Altered Sensation *  5/11 (45.45%)  5
Edema *  3/11 (27.27%)  3
Warm sensation on treatment area *  2/11 (18.18%)  2
Surface sensitivity/soreness at treatment site *  2/11 (18.18%)  2
Itching *  1/11 (9.09%)  1
Bruising at attempted IV site *  1/11 (9.09%)  1
Burning sensation to touch *  1/11 (9.09%)  1
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Investigator shall notify Sponsor of the intent to publish or present independent Study Data, and agrees not to publish or publicly present and/or discuss such data, Investigator's current findings and/or the results of the Study independently without the express written consent of Sponsor, which consent may be withheld. Prior to submission for publication or presentation, all draft manuscripts must be submitted, reviewed and approved by Sponsor for confidential material.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Director of Clinical Programs
Organization: Solta Medical
Phone: 510-259-5284
EMail: aloncaric@solta.com
Layout table for additonal information
Responsible Party: Valeant Pharmaceuticals ( Solta Medical )
ClinicalTrials.gov Identifier: NCT01993238    
Other Study ID Numbers: 13-140-LP-H
First Submitted: November 11, 2013
First Posted: November 25, 2013
Results First Submitted: March 25, 2014
Results First Posted: April 29, 2014
Last Update Posted: April 29, 2014