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Efficacy and Safety of the DTS-G2 System in Patients With Axillary Hyperhidrosis (DRI-UP)

This study has been completed.
Sponsor:
Information provided by:
Miramar Labs
ClinicalTrials.gov Identifier:
NCT00931359
First received: June 28, 2009
Last updated: June 13, 2011
Last verified: June 2011
Results First Received: April 15, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Primary Focal Hyperhidrosis, Axilla
Interventions: Device: DTS-G2 System
Device: DTS System (Sham treatment)

  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
Sham Treatment Subjects received a sham treatment in two treatment sessions.
Treatment With DTS-G2 System Subjects received treatment in one to three treatment sessions with fixed device settings. Settings were at a generator output energy of 220J.

Participant Flow:   Overall Study
    Sham Treatment     Treatment With DTS-G2 System  
STARTED     39     81  
COMPLETED     33     68  
NOT COMPLETED     6     13  



  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
Sham Treatment Subjects received a sham treatment in two treatment sessions.
Treatment With DTS-G2 System Subjects received treatment in one to three treatment sessions with fixed device settings. Settings were at a generator output energy of 220J.
Total Total of all reporting groups

Baseline Measures
    Sham Treatment     Treatment With DTS-G2 System     Total  
Number of Participants  
[units: participants]
  39     81     120  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     39     80     119  
>=65 years     0     1     1  
Age  
[units: years]
Mean ± Standard Deviation
  34.1  ± 11.2     32.2  ± 10.7     32.8  ± 10.8  
Gender  
[units: participants]
     
Female     26     44     70  
Male     13     37     50  
Region of Enrollment  
[units: participants]
     
United States     39     81     120  



  Outcome Measures
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1.  Primary:   Percentage of Subjects That Report an HDSS Score of 1 or 2 at 30 Days.   [ Time Frame: 30 days post-treatment ]

2.  Secondary:   Percentage of Subjects That Report an HDSS Score of 1 or 2 at the 6 Month Follow-up Visit.   [ Time Frame: 6 months post-treatment ]

3.  Secondary:   Percentage of Treatment Group Subjects That Report an HDSS Score of 1 or 2 at the 12 Month Visit   [ Time Frame: 12 months ]

4.  Secondary:   Percentage of Subjects With Reported Adverse Events   [ Time Frame: 6 months post-treatment ]


  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
Sham subjects exited the study at 6 months, so group comparisons are not possible for later timepoints.


  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.


Results Point of Contact:  
Name/Title: Kathy O'Shaughnessy, PhD
Organization: Miramar Labs
phone: 408-940-8700
e-mail: kathyo@miramarlabs.com


No publications provided


Responsible Party: Kathy O'Shaughnessy, VP Clinical/Regulatory, Miramar Labs, Inc
ClinicalTrials.gov Identifier: NCT00931359     History of Changes
Other Study ID Numbers: CP-0003
Study First Received: June 28, 2009
Results First Received: April 15, 2011
Last Updated: June 13, 2011
Health Authority: United States: Food and Drug Administration