The Efficacy of the Cupola Ultrasonic Tattoo Removal Device

This study has been terminated.
(Sponsor decided that the results were not significant enough to continue.)
Sponsor:
Information provided by (Responsible Party):
Cupola Medical Ltd
ClinicalTrials.gov Identifier:
NCT01516034
First received: January 16, 2012
Last updated: November 22, 2012
Last verified: November 2012
Results First Received: November 9, 2012  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Tattooing
Intervention: Device: Cupola Tattoo Removal 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
Recruitment period: 20-Nov-2011 to 11-Mar-12 Location: Dermatological clinic

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
Treatment Cupola tattoo removal treatment

Participant Flow:   Overall Study
    Treatment  
STARTED     8  
COMPLETED     0  
NOT COMPLETED     8  
Physician Decision                 1  
Lack of Efficacy                 7  



  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
Treatment Cupola tattoo removal treatment

Baseline Measures
    Treatment  
Number of Participants  
[units: participants]
  8  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     8  
>=65 years     0  
Age  
[units: years]
Mean ± Standard Deviation
  32.1  ± 6.3  
Gender  
[units: participants]
 
Female     0  
Male     8  
Region of Enrollment  
[units: participants]
 
Israel     8  



  Outcome Measures

1.  Primary:   Tattoo Removal Efficiency   [ Time Frame: 6 months (termination) ]

2.  Secondary:   Tolerability Score   [ Time Frame: 0, 2, 4, 6, 8, 10 weeks (after every treatment) ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No


  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 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
No text entered.  


Results Point of Contact:  
Name/Title: David J. Friedman, Principal Investigator
Organization: Dr David Friedman Laser & Skin Center
phone: +972-2-5635673
e-mail: drfriedmanlaser@gmail.com


No publications provided


Responsible Party: Cupola Medical Ltd
ClinicalTrials.gov Identifier: NCT01516034     History of Changes
Other Study ID Numbers: CTR-2
Study First Received: January 16, 2012
Results First Received: November 9, 2012
Last Updated: November 22, 2012
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration