Prometra Post-Approval Study

October 17, 2023 updated by: Flowonix Medical

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
400

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • La Jolla, California, United States, 92037
        • Perlman Clinic
      • Santa Barbara, California, United States, 93105
        • Pacific Pain Physicians
      • Santa Barbara, California, United States, 95403
        • Evolve Restorative Center
      • Santa Rosa, California, United States, 95401
        • Summit Pain Alliance
      • Torrance, California, United States, 90260
        • BioHealth Pain Management
    • Florida
      • Daytona Beach, Florida, United States, 32174
        • Interventional Pain Management
      • Jacksonville, Florida, United States, 32257
        • Florida Institute of Medical Research
      • Lake Worth, Florida, United States, 33462
        • Palm Beach Pain Management
      • Tampa, Florida, United States, 33603
        • Pain Institute of Tampa
    • Indiana
      • Evansville, Indiana, United States, 47714
        • Global Scientific Innovations
      • Fort Wayne, Indiana, United States, 46802
        • Summit Pain Management
      • Fort Wayne, Indiana, United States, 46825
        • Summit Research Institute
    • Kansas
      • Overland Park, Kansas, United States, 66209
        • Interventional Pain Management Specialists
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Bluegrass Pain Consultants
      • Louisville, Kentucky, United States, 40241
        • Kentuckiana Pain Specialists
    • Louisiana
      • Covington, Louisiana, United States, 70433
        • Neuroscience and Pain Institute
      • New Orleans, Louisiana, United States, 70115
        • Integrated Pain and Neuroscience
    • Mississippi
      • Jackson, Mississippi, United States, 39202
        • Jackson Anesthesia Pain Center
    • North Carolina
      • Asheville, North Carolina, United States, 28803
        • Triumph Medical
    • Ohio
      • Columbus, Ohio, United States, 43219-1531
        • Integrated Pain Solutions
      • Wooster, Ohio, United States, 44691
        • Pain Management Institute
    • Oregon
      • Eugene, Oregon, United States, 97401
        • NeuroSpine Institute
      • Medford, Oregon, United States, 97504
        • Pain Care of Oregon
    • Pennsylvania
      • Trevose, Pennsylvania, United States, 19053
        • Fox Chase Pain Management Associates
    • Texas
      • Webster, Texas, United States, 77598
        • Space City Pain Specialists
    • Utah
      • Provo, Utah, United States, 84604
        • Nexus Pain Care

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

22 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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 Names:
  • 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 Names:
  • Flowonix pump

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Five years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Pump failure
Time Frame: Five years
Tabulation of pump failures, including time to occurrence and type
Five years
Pump battery life
Time Frame: Five years
Tabulation of occurences of premature pump battery depletions
Five years

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Device-related adverse events
Time Frame: Five years
Tabulation of device-related adverse events
Five years
Device-related serious adverse events
Time Frame: Five years
Tabulation of device-related serious adverse events
Five years
Rate of granuloma formation by race and ethnicity
Time Frame: Five years
The effect of race and ethnicity on granuloma formation
Five years
Granuloma formation by drug type
Time Frame: Five years
The effect of alternative drugs on granuloma formation
Five years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Flowonix Medical

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Cory Brantley, Flowonix Medical

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 20, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 15, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 15, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 13, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 13, 2013

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 15, 2013

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 18, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 17, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PAS-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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