Thigh Circumference Reduction Study

This study has been terminated.
(The study was terminated because the preliminary data did not indicate efficacy.)
Sponsor:
Information provided by:
Cutera Inc.
ClinicalTrials.gov Identifier:
NCT00953290
First received: August 4, 2009
Last updated: May 6, 2011
Last verified: May 2011
Results First Received: February 17, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Reduction of Localized Excess Fat
Intervention: Device: Cutera Radio Frequency Device

  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
The study subjects were recruited in the medical clinic 01/30/09 through 04/07/09.

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
Treated and Untreated Thigh Circumference measurement of RF treated thigh compared to untreated thigh (average of 2.8 treatments and average dosage of 27 kJ) on the same subject

Participant Flow:   Overall Study
    Treated and Untreated Thigh  
STARTED     4  
COMPLETED     4  
NOT COMPLETED     0  



  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
Treated And Untreated Thigh Treated and untreated arms (left and right thighs) on the same subject.

Baseline Measures
    Treated And Untreated Thigh  
Number of Participants  
[units: participants]
  4  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     4  
>=65 years     0  
Age  
[units: years]
Mean ± Standard Deviation
  43  ± 10.98  
Gender  
[units: participants]
 
Female     4  
Male     0  
Region of Enrollment  
[units: participants]
 
United States     4  



  Outcome Measures
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1.  Primary:   Difference in Circumference of Upper Thigh Between Treated and Untreated Control Arms   [ Time Frame: Baseline and 6 months post final treatment ]

2.  Primary:   Difference in Circumference of Mid Thigh Between Treated and Untreated Control Arms   [ Time Frame: Baseline and 6 months post final treatment ]

3.  Secondary:   Subject Satisfaction   [ Time Frame: Baseline and 6 months post final treatment ]

4.  Secondary:   Adverse Events   [ Time Frame: At each visit (treatment and follow-up) or until resolution of AEs ]


  Serious Adverse Events


  Other Adverse Events


  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.


Limitations and Caveats
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
Early termination of the study resulting in analysis of small numbers of subjects, and technical issues with repeatability and reproducibility of circumference measurements leading to termination.  


Results Point of Contact:  
Name/Title: Ayse Turley, Clinical Development Researcher
Organization: Cutera Inc.
phone: 415-657-5665
e-mail: aturley@cutera.com


No publications provided


Responsible Party: Stephanie Buech, Director of Clinical Research, Cutera Inc.
ClinicalTrials.gov Identifier: NCT00953290     History of Changes
Other Study ID Numbers: CTCS002
Study First Received: August 4, 2009
Results First Received: February 17, 2011
Last Updated: May 6, 2011
Health Authority: United States: Institutional Review Board