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Prometra Post-Approval Study

Primary Purpose

Chronic Pain, Cancer Pain, Intractable Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Prometra Programmable Intrathecal Infusion Pump
Sponsored by
Flowonix Medical
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Pain focused on measuring Morphine, Implantable Infusion Pumps, Intrathecal Pump

Eligibility Criteria

22 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Perlman Clinic
  • Pacific Pain Physicians
  • Evolve Restorative Center
  • Summit Pain Alliance
  • BioHealth Pain Management
  • Interventional Pain Management
  • Florida Institute of Medical Research
  • Palm Beach Pain Management
  • Pain Institute of Tampa
  • Global Scientific Innovations
  • Summit Pain Management
  • Summit Research Institute
  • Interventional Pain Management Specialists
  • Bluegrass Pain Consultants
  • Kentuckiana Pain Specialists
  • Neuroscience and Pain Institute
  • Integrated Pain and Neuroscience
  • Jackson Anesthesia Pain Center
  • Triumph Medical
  • Integrated Pain Solutions
  • Pain Management Institute
  • Neurospine Institute
  • Pain Care of Oregon
  • Fox Chase Pain Management Associates
  • Space City Pain Specialists
  • Nexus Pain Care

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Prospective pump candidates

Previous IDE study subjects continuing with the therapy

Arm Description

New candidates who will receive the Prometra Programmable Intrathecal Infusion Pump

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.

Outcomes

Primary Outcome Measures

Rate of granuloma formation
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

Pump failure
Tabulation of pump failures, including time to occurrence and type
Pump battery life
Tabulation of occurences of premature pump battery depletions

Full Information

First Posted
May 13, 2013
Last Updated
October 17, 2023
Sponsor
Flowonix Medical
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1. Study Identification

Unique Protocol Identification Number
NCT01854229
Brief Title
Prometra Post-Approval Study
Official Title
A Prospective, Non-randomized, Open-label, Multicenter Study to Evaluate the Long-term Safety of the Prometra Programmable Pump System
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
June 20, 2013 (Actual)
Primary Completion Date
March 15, 2023 (Actual)
Study Completion Date
March 15, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Flowonix Medical

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain, Cancer Pain, Intractable Pain, Back Pain
Keywords
Morphine, Implantable Infusion Pumps, Intrathecal Pump

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
400 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Prospective pump candidates
Arm Type
Active Comparator
Arm Description
New candidates who will receive the Prometra Programmable Intrathecal Infusion Pump
Arm Title
Previous IDE study subjects continuing with the therapy
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Prometra Programmable Intrathecal Infusion Pump
Other Intervention Name(s)
Flowonix pump
Intervention Description
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.
Primary Outcome Measure Information:
Title
Rate of granuloma formation
Description
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.
Time Frame
Five years
Secondary Outcome Measure Information:
Title
Pump failure
Description
Tabulation of pump failures, including time to occurrence and type
Time Frame
Five years
Title
Pump battery life
Description
Tabulation of occurences of premature pump battery depletions
Time Frame
Five years
Other Pre-specified Outcome Measures:
Title
Device-related adverse events
Description
Tabulation of device-related adverse events
Time Frame
Five years
Title
Device-related serious adverse events
Description
Tabulation of device-related serious adverse events
Time Frame
Five years
Title
Rate of granuloma formation by race and ethnicity
Description
The effect of race and ethnicity on granuloma formation
Time Frame
Five years
Title
Granuloma formation by drug type
Description
The effect of alternative drugs on granuloma formation
Time Frame
Five years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cory Brantley
Organizational Affiliation
Flowonix Medical
Official's Role
Study Director
Facility Information:
Facility Name
Perlman Clinic
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Pacific Pain Physicians
City
Santa Barbara
State/Province
California
ZIP/Postal Code
93105
Country
United States
Facility Name
Evolve Restorative Center
City
Santa Barbara
State/Province
California
ZIP/Postal Code
95403
Country
United States
Facility Name
Summit Pain Alliance
City
Santa Rosa
State/Province
California
ZIP/Postal Code
95401
Country
United States
Facility Name
BioHealth Pain Management
City
Torrance
State/Province
California
ZIP/Postal Code
90260
Country
United States
Facility Name
Interventional Pain Management
City
Daytona Beach
State/Province
Florida
ZIP/Postal Code
32174
Country
United States
Facility Name
Florida Institute of Medical Research
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32257
Country
United States
Facility Name
Palm Beach Pain Management
City
Lake Worth
State/Province
Florida
ZIP/Postal Code
33462
Country
United States
Facility Name
Pain Institute of Tampa
City
Tampa
State/Province
Florida
ZIP/Postal Code
33603
Country
United States
Facility Name
Global Scientific Innovations
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47714
Country
United States
Facility Name
Summit Pain Management
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46802
Country
United States
Facility Name
Summit Research Institute
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46825
Country
United States
Facility Name
Interventional Pain Management Specialists
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66209
Country
United States
Facility Name
Bluegrass Pain Consultants
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Kentuckiana Pain Specialists
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40241
Country
United States
Facility Name
Neuroscience and Pain Institute
City
Covington
State/Province
Louisiana
ZIP/Postal Code
70433
Country
United States
Facility Name
Integrated Pain and Neuroscience
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70115
Country
United States
Facility Name
Jackson Anesthesia Pain Center
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39202
Country
United States
Facility Name
Triumph Medical
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28803
Country
United States
Facility Name
Integrated Pain Solutions
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43219-1531
Country
United States
Facility Name
Pain Management Institute
City
Wooster
State/Province
Ohio
ZIP/Postal Code
44691
Country
United States
Facility Name
Neurospine Institute
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97401
Country
United States
Facility Name
Pain Care of Oregon
City
Medford
State/Province
Oregon
ZIP/Postal Code
97504
Country
United States
Facility Name
Fox Chase Pain Management Associates
City
Trevose
State/Province
Pennsylvania
ZIP/Postal Code
19053
Country
United States
Facility Name
Space City Pain Specialists
City
Webster
State/Province
Texas
ZIP/Postal Code
77598
Country
United States
Facility Name
Nexus Pain Care
City
Provo
State/Province
Utah
ZIP/Postal Code
84604
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
23057877
Citation
Rauck R, Deer T, Rosen S, Padda G, Barsa J, Dunbar E, Dwarakanath G. Long-term follow-up of a novel implantable programmable infusion pump. Neuromodulation. 2013 Mar-Apr;16(2):163-7. doi: 10.1111/j.1525-1403.2012.00515.x. Epub 2012 Oct 11.
Results Reference
background
Links:
URL
http://www.painmed.org/
Description
American Academy of Pain Medicine
URL
http://www.neuromodulation.org/
Description
North American Neuromodulation Society
URL
http://www.asra.com/
Description
American Society of Regional Anesthesia and Pain Medicine
URL
https://www.worldinstituteofpain.org
Description
World Institute of Pain

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Prometra Post-Approval Study

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