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Application of the Apsara Thermal Wand System

This study has been completed.
Sponsor:
Information provided by:
Apsara Medical Corporation
ClinicalTrials.gov Identifier:
NCT00662389
First received: April 17, 2008
Last updated: July 22, 2009
Last verified: July 2009
History of Changes
Results First Received: July 22, 2009  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Tightening of Skin Laxity
Intervention: Device: Apsara Thermal Wand 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
A--Thermal Wand Application No text entered.

Participant Flow:   Overall Study
    A--Thermal Wand Application  
STARTED     4  
COMPLETED     4  
NOT COMPLETED     0  



  Baseline Characteristics
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Reporting Groups
  Description
A--Thermal Wand Application No text entered.

Baseline Measures
    A--Thermal Wand Application  
Number of Participants  
[units: participants]
 		  4  
Age  
[units: participants]
 		 
<=18 years     0  
Between 18 and 65 years     3  
>=65 years     1  
Age  
[units: years]
Mean ± Standard Deviation 		  61.7  ± 3.6  
Gender  
[units: participants]
 		 
Female     4  
Male     0  
Region of Enrollment  
[units: participants]
 		 
United States     4  



  Outcome Measures

1.  Primary:   Serious Adverse Events   [ Time Frame: Immediate ]
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Measure Type Primary
Measure Title Serious Adverse Events
Measure Description Number of Serious Adverse Events
Time Frame Immediate  
Safety Issue Yes  

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
A--Thermal Wand Application No text entered.

Measured Values
    A--Thermal Wand Application  
Number of Participants Analyzed  
[units: participants]
 		  4  
Serious Adverse Events  
[units: Number of Serious Adverse Events]
 		  0  

No statistical analysis provided for Serious Adverse Events




  Serious Adverse Events
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  Other Adverse Events
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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 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.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


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
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Results Point of Contact:  
Name/Title: Eve Conner, Ph.D. Consultant
Organization: Apsara Medical Corporation
phone: 510 566-2495
e-mail: eaconner@sbcglobal.net


No publications provided


Responsible Party: Kim Tompkins, VP, Clinical/Regulatory/Quality
ClinicalTrials.gov Identifier: NCT00662389     History of Changes
Other Study ID Numbers: NEIRB08-090
Study First Received: April 17, 2008
Results First Received: July 22, 2009
Last Updated: July 22, 2009
Health Authority: United States: Institutional Review Board