Prometra's Utilization in Mitigating Pain (PUMP)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Flowonix Medical
ClinicalTrials.gov Identifier:
NCT00817596
First received: January 5, 2009
Last updated: August 13, 2012
Last verified: August 2012
Results First Received: March 2, 2012  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Intractable Pain
Intervention: Device: Infusion Pump (Prometra)

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Prometra Intrathecal Pump System This group was treated with an intrathecal pump implant. Pumps were filled with morphine sulfate. Dosage, concentration, and other programmable parameters were prescribed at the discretion of the physician.

Participant Flow:   Overall Study
    Prometra Intrathecal Pump System  
STARTED     110  
COMPLETED     62  
NOT COMPLETED     48  



  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.
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Reporting Groups
  Description
Prometra Intrathecal Pump System This group was treated with an intrathecal pump implant. Pumps were filled with morphine sulfate. Dosage, concentration, and other programmable parameters were prescribed at the discretion of the physician.

Baseline Measures
    Prometra Intrathecal Pump System  
Number of Participants  
[units: participants]
  110  
Age  
[units: years]
Mean ± Standard Deviation
  56  ± 13  
Gender  
[units: participants]
 
Female     51  
Male     59  



  Outcome Measures

1.  Primary:   Demonstrate That Prometra Programmable Pump System Accurately and Safely Delivers Medication in the Intrathecal Space, as Programmed.   [ Time Frame: 6 months - acute study ]


  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
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Results Point of Contact:  
Name/Title: Clinical Trials Manager
Organization: Medasys, Inc.
phone: 973-426-9229
e-mail: jarrambide@medasyspumps.com


No publications provided


Responsible Party: Flowonix Medical
ClinicalTrials.gov Identifier: NCT00817596     History of Changes
Other Study ID Numbers: G060192
Study First Received: January 5, 2009
Results First Received: March 2, 2012
Last Updated: August 13, 2012
Health Authority: United States: Food and Drug Administration