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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:
ClinicalTrials.gov Identifier:
NCT00931359
First Posted: July 2, 2009
Last Update Posted: June 15, 2011
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.
Information provided by:
Miramar Labs
Results First Submitted: April 15, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, 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 
Overall Participants Analyzed 
[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



Responsible Party: Kathy O'Shaughnessy, VP Clinical/Regulatory, Miramar Labs, Inc
ClinicalTrials.gov Identifier: NCT00931359     History of Changes
Other Study ID Numbers: CP-0003
First Submitted: June 28, 2009
First Posted: July 2, 2009
Results First Submitted: April 15, 2011
Results First Posted: June 14, 2011
Last Update Posted: June 15, 2011