Chronic PainNCT01854229
Prometra Post-Approval Study
A study testing Prometra Programmable Intrathecal Infusion Pump in people with Chronic Pain and Cancer Pain, run by Flowonix Medical at 26 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Chronic Pain, Cancer Pain, Intractable Pain
- What is being tested?
- Prometra Programmable Intrathecal Infusion Pump
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 26 sitesUnited States
- Study dates
- 20 Jun 2013to 15 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
26 sites in 1 country.
26 sites in 1 country
United States26 sites
Triumph Medical
Asheville, North Carolina, 28803
Integrated Pain Solutions
Columbus, Ohio, 43219-1531
Neuroscience and Pain Institute
Covington, Louisiana, 70433
Interventional Pain Management
Daytona Beach, Florida, 32174
Neurospine Institute
Eugene, Oregon, 97401
Global Scientific Innovations
Evansville, Indiana, 47714
Summit Pain Management
Fort Wayne, Indiana, 46802
Summit Research Institute
Fort Wayne, Indiana, 46825
Jackson Anesthesia Pain Center
Jackson, Mississippi, 39202
Florida Institute of Medical Research
Jacksonville, Florida, 32257
Perlman Clinic
La Jolla, California, 92037
Palm Beach Pain Management
Lake Worth, Florida, 33462
Bluegrass Pain Consultants
Louisville, Kentucky, 40202
Kentuckiana Pain Specialists
Louisville, Kentucky, 40241
Pain Care of Oregon
Medford, Oregon, 97504
Integrated Pain and Neuroscience
New Orleans, Louisiana, 70115
Interventional Pain Management Specialists
Overland Park, Kansas, 66209
Nexus Pain Care
Provo, Utah, 84604
Pacific Pain Physicians
Santa Barbara, California, 93105
Evolve Restorative Center
Santa Barbara, California, 95403
Summit Pain Alliance
Santa Rosa, California, 95401
Pain Institute of Tampa
Tampa, Florida, 33603
BioHealth Pain Management
Torrance, California, 90260
Fox Chase Pain Management Associates
Trevose, Pennsylvania, 19053
Space City Pain Specialists
Webster, Texas, 77598
Pain Management Institute
Wooster, Ohio, 44691
About this study
Official title: 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.
Read the 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.
- Conditions
- Chronic Pain, Cancer Pain, Intractable Pain, Back Pain
- Being tested
- Prometra Programmable Intrathecal Infusion Pump
- Keywords
- Morphine, Implantable Infusion Pumps, Intrathecal Pump
- Medical subject headings
- Chronic Pain, Cancer Pain, Pain, Intractable, Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prometra Programmable Intrathecal Infusion PumpDevice
Also called Flowonix 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.
| Study group | Role | What they receive |
|---|---|---|
| Prospective pump candidates | Active comparator | New candidates who will receive the Prometra Programmable Intrathecal Infusion Pump Receives: Device: Prometra Programmable Intrathecal Infusion Pump |
| Previous IDE study subjects continuing with the therapy | Active comparator | 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. Receives: Device: Prometra Programmable Intrathecal Infusion Pump |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Five years
Secondary outcomes (2)
Pump failure
Tabulation of pump failures, including time to occurrence and type
Measured: Five years
Pump battery life
Tabulation of occurences of premature pump battery depletions
Measured: Five years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2013 (estimated)
- Study start20 Jun 2013
- Primary completion15 Mar 2023
- Study completion15 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Flowonix Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Cory Brantley, Study director, Flowonix Medical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01854229
- Sponsor's protocol ID
- PAS-01
- Status last verified
- Oct 2023
- First submitted
- 13 May 2013
- Last updated
- 18 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 23057877
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Non-randomized, Open-label, Multicenter Study to Evaluate the Long-term Safety of the Prometra Programmable Pump System
- ClinicalTrials.gov ID
- NCT01854229
- Acronym / sponsor ID
- PAS-01
- Conditions
- Chronic Pain, Cancer Pain, Intractable Pain, Back Pain
- Keywords
- Morphine, Implantable Infusion Pumps, Intrathecal Pump
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Flowonix MedicalIndustry (pharma, biotech, devices)
- Study start
- 20 Jun 2013 (actual)
- Primary completion
- 15 Mar 2023 (actual)
- Study completion
- 15 Mar 2023 (actual)
- First posted
- 15 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prospective pump candidates | Active comparator | Device: Prometra Programmable Intrathecal Infusion PumpNew candidates who will receive the Prometra Programmable Intrathecal Infusion Pump |
| Previous IDE study subjects continuing with the therapy | Active comparator | Device: Prometra Programmable Intrathecal Infusion PumpPatients 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. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patient meets at least one of the following:
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prometra Programmable Intrathecal Infusion PumpAlso: Flowonix pumpThere 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. | Device | Previous IDE study subjects continuing with the therapy, Prospective pump candidates |
Primary outcome
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.
2 secondary outcomes
Pump failure
Time frame: Five years
Pump battery life
Time frame: Five years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2023.
- Background: PubMed 23057877Rauck 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.
- American Academy of Pain MedicineLink provided by the sponsor.
- North American Neuromodulation SocietyLink provided by the sponsor.
- American Society of Regional Anesthesia and Pain MedicineLink provided by the sponsor.
- World Institute of PainLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cory Brantley study director
Flowonix Medical
26 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prometra Programmable Intrathecal Infusion Pump in people with Chronic Pain and Cancer Pain, run by Flowonix Medical at 26 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of granuloma formation (time frame: Five years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01854229, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2023.