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

History of Changes

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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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 ]

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Serious Adverse Events

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Other Adverse Events

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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:

	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.
	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 more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	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

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