Study of the Cabochon System for Improvement in the Appearance of Cellulite

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Cabochon Aesthetics, Inc.
ClinicalTrials.gov Identifier:
NCT01671839
First received: August 17, 2012
Last updated: September 3, 2014
Last verified: September 2014
Results First Received: July 25, 2014  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Gynoid Lipodystrophy
Intervention: Device: Subcutaneous tissue release with the Cabochon System

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Subcutaneous Tissue Release

Device: Subcutaneous tissue release with the Cabochon System

Subcutaneous tissue release with the Cabochon System: Device: Subcutaneous tissue release


Participant Flow:   Overall Study
    Subcutaneous Tissue Release  
STARTED     55  
COMPLETED     50  
NOT COMPLETED     5  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Subcutaneous Tissue Release

Device: Subcutaneous tissue release with the Cabochon System

Subcutaneous tissue release with the Cabochon System: Device: Subcutaneous tissue release


Baseline Measures
    Subcutaneous Tissue Release  
Number of Participants  
[units: participants]
  55  
Age  
[units: Years]
Mean ± Standard Deviation
  40.7  ± 9.1  
Gender  
[units: participants]
 
Female     55  
Male     0  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Mean Change in Cellulite Severity   [ Time Frame: Treatment to 1 year ]

2.  Secondary:   Improvement in Cellulite Severity Grade   [ Time Frame: 1-year ]

3.  Secondary:   Improved Appearance   [ Time Frame: Treatment to 1 year ]

4.  Secondary:   Subject Satisfaction   [ Time Frame: Treatment to 1 year ]

5.  Secondary:   Procedure Tolerability   [ Time Frame: Treatment to 1 year ]

6.  Secondary:   Safe Treatment   [ Time Frame: Treatment to 1 year ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Lisa Misell, Ph.D., VP, Clinical and Medical Affairs
Organization: Ulthera, Inc. 1840 South Stapley Drive, Mesa, AZ 85204
phone: 480-619-4069
e-mail: l.misell@ulthera.com


No publications provided


Responsible Party: Cabochon Aesthetics, Inc.
ClinicalTrials.gov Identifier: NCT01671839     History of Changes
Other Study ID Numbers: CP-01-1004
Study First Received: August 17, 2012
Results First Received: July 25, 2014
Last Updated: September 3, 2014
Health Authority: United States: Food and Drug Administration