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Prometra Post-Approval Study

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ClinicalTrials.gov Identifier: NCT01854229
Recruitment Status : Suspended
First Posted : May 15, 2013
Last Update Posted : April 10, 2018
Sponsor:
Information provided by (Responsible Party):
Flowonix Medical

Brief Summary:
The Prometra Pump is approved by the FDA for use in the United States. The purpose of this study is to collect long-term safety data on the Prometra Pump.

Condition or disease Intervention/treatment Phase
Chronic Pain Cancer Pain Intractable Pain Back Pain Device: Prometra Programmable Intrathecal Infusion Pump Not Applicable

Detailed Description:
This study is proposed under part of the post-Premarket Approval (PMA) requirements. This study is a prospective, non-randomized, open-label, multicenter study. It will be performed at 10-30 centers in the US and enroll a maximum of 400 subjects. Subjects will be followed for a total of five years.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Non-randomized, Open-label, Multicenter Study to Evaluate the Long-term Safety of the Prometra Programmable Pump System
Actual Study Start Date : June 20, 2013
Estimated Primary Completion Date : February 2022
Estimated Study Completion Date : August 2022

Arm Intervention/treatment
Active Comparator: Prospective pump candidates
New candidates who will receive the Prometra Programmable Intrathecal Infusion Pump
Device: Prometra Programmable Intrathecal Infusion Pump
There are two enrollment groups (arms). One is for new patients who are going to have a Prometra Pump implanted. The other arm is for patients who were part of the IDE study prior to FDA approval of the pump, and are willing to continue to be followed as part of a study.
Other Name: Flowonix pump

Active Comparator: Previous IDE study subjects continuing with the therapy
Patients who were part of the previous IDE study, still have an active Prometra Programmable Intrathecal Infusion Pump, and are willing to continue in a study protocol.
Device: Prometra Programmable Intrathecal Infusion Pump
There are two enrollment groups (arms). One is for new patients who are going to have a Prometra Pump implanted. The other arm is for patients who were part of the IDE study prior to FDA approval of the pump, and are willing to continue to be followed as part of a study.
Other Name: Flowonix pump




Primary Outcome Measures :
  1. Rate of granuloma formation [ Time Frame: Five years ]
    The primary hypothesis is that the 5-year rate of patients with granuloma formation will be noninferior to that in the literature. The literature rate was found to be approximately 3% and the noninferiority margin will be three percentage points.


Secondary Outcome Measures :
  1. Pump failure [ Time Frame: Five years ]
    Tabulation of pump failures, including time to occurrence and type

  2. Pump battery life [ Time Frame: Five years ]
    Tabulation of occurences of premature pump battery depletions


Other Outcome Measures:
  1. Device-related adverse events [ Time Frame: Five years ]
    Tabulation of device-related adverse events

  2. Device-related serious adverse events [ Time Frame: Five years ]
    Tabulation of device-related serious adverse events

  3. Rate of granuloma formation by race and ethnicity [ Time Frame: Five years ]
    The effect of race and ethnicity on granuloma formation

  4. Granuloma formation by drug type [ Time Frame: Five years ]
    The effect of alternative drugs on granuloma formation



Information from the National Library of Medicine

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Ages Eligible for Study:   22 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patient meets at least one of the following:

    • is suffering from malignant pain (i.e., cancer pain)
    • has chronic, non-malignant pain
    • subject was enrolled in PUMP I or PUMP II study and chooses to participate in this Post-Approval study
    • Patient with an existing implantable pump for pain therapy that requires replacement
  2. Patient is at least 22 years of age.
  3. Investigator considers the patient to be able and willing to fulfill all study requirements.
  4. Patient has provided written informed consent to participate in the study.

Exclusion Criteria:

  1. Patient meets any of the contraindications for use of the Prometra System
  2. Patient has a prior history of granuloma formation, or is receiving treatment for a suspected granuloma.
  3. Patient is pregnant or breast-feeding or is of child-bearing potential and not employing effective birth control.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01854229


  Show 28 Study Locations
Sponsors and Collaborators
Flowonix Medical
Investigators
Study Director: Karen Matis Flowonix Medical

Additional Information:
Publications:
Responsible Party: Flowonix Medical
ClinicalTrials.gov Identifier: NCT01854229     History of Changes
Other Study ID Numbers: PAS-01
First Posted: May 15, 2013    Key Record Dates
Last Update Posted: April 10, 2018
Last Verified: April 2018

Keywords provided by Flowonix Medical:
Morphine
Implantable Infusion Pumps
Intrathecal Pump

Additional relevant MeSH terms:
Back Pain
Chronic Pain
Cancer Pain
Pain, Intractable
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms