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The Efficacy of the Cupola Ultrasonic Tattoo Removal Device

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: NCT01516034
Recruitment Status : Terminated (Sponsor decided that the results were not significant enough to continue.)
First Posted : January 24, 2012
Results First Posted : December 21, 2012
Last Update Posted : December 21, 2012
Information provided by (Responsible Party):
Cupola Medical Ltd

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Tattooing
Intervention: Device: Cupola Tattoo Removal device

  Participant Flow

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
Treatment Cupola tattoo removal treatment

Participant Flow:   Overall Study
Physician Decision                1 
Lack of Efficacy                7 

  Baseline Characteristics

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
Treatment Cupola tattoo removal treatment

Baseline Measures
Overall Participants Analyzed 
[Units: Participants]
[Units: Participants]
<=18 years   0 
Between 18 and 65 years   8 
>=65 years   0 
[Units: Years]
Mean (Standard Deviation)
 32.1  (6.3) 
[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 reported.   Anticipated Reporting Date:   No text entered.  

  Serious Adverse Events

  Other Adverse Events

  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.

  More Information

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.

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

Responsible Party: Cupola Medical Ltd
ClinicalTrials.gov Identifier: NCT01516034     History of Changes
Other Study ID Numbers: CTR-2
First Submitted: January 16, 2012
First Posted: January 24, 2012
Results First Submitted: November 9, 2012
Results First Posted: December 21, 2012
Last Update Posted: December 21, 2012