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Completed

NCT Number: NCT01854229

Prometra Post-Approval Study

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.

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Key information

Conditions

Chronic Pain Back Pain Cancer Pain Intractable Pain Neurologic Manifestations Pain Pain, Intractable Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

22 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Perlman Clinic, La Jolla, California, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • Patient is at least 22 years of age.
  • Investigator considers the patient to be able and willing to fulfill all study requirements.
  • Patient has provided written informed consent to participate in the study.

Exclusion criteria

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

Treatment and study plan

Prometra Programmable Intrathecal Infusion Pump

Device

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 names: Flowonix pump

Primary outcomes

  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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Flowonix Medical

Industry

Registry information

Official study title

A Prospective, Non-randomized, Open-label, Multicenter Study to Evaluate the Long-term Safety of the Prometra Programmable Pump System

Important dates

Study start
2013
Primary completion
2023
Study completion
2023
First posted
May 15, 2013
Registry last updated
Oct 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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