Intractable Pain(PUMP 2)NCT00866164
Prometra's Utilization in Mitigating Pain II
A study testing Prometra Programmable Pump in people with Intractable Pain and Back Pain, run by Flowonix Medical.
Trial summary
Intrathecal infusion pumps are increasingly used to deliver analgesics for chronic intractable pain. The PUMP II trial is designed to evaluate the ongoing safety and efficacy of the new Prometra® Programmable Pump System for intrathecal administration of morphine sulfate to treat chronic intractable pain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intractable Pain, Back Pain, Leg Pain
- What is being tested?
- Prometra Programmable Pump
- Type of treatment
- Medical device
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Expanded access
- 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 18 years and older
- All sexes
- Adult, Older adult
Who may be able to join
- Patient is suffering from cancer pain requiring strong opioids (e.g., fentanyl, methadone, levorphanol, hydromorphone, oxymorphone, oxycodone) OR Patient has chronic, non-malignant pain OR Patient needs an implantable pump system (pump AND catheter) replaced due to malfunction or battery depletion. Patient must have documented history of sufficient pain relief with intrathecal morphine sulfate infusion.
- Patient is 18 years of age or older.
- Patient has life expectancy of > 6 months.
- Patient has documented failure to respond to less invasive methods of pain control, including attempts to eliminate physical and behavioral abnormalities that may cause an exaggerated reaction to pain.
- Patient has pain that is ineffectively controlled by single or multiple systemic (oral, rectal, transdermal or intravenous) analgesic treatments or patient experienced intolerable side effects from such treatment.
- Patient has had a successful trial of morphine sulfate (intrathecal or epidural) for relief of the target symptoms.
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- Patient agrees to obtain pain medication prescriptions only from the investigator.
- Patient has provided written informed consent to participate in the study.
- Patient is considered by the investigator to be a medically and psychologically appropriate candidate for pump implantation.
- Investigator and/or study coordinator considers the patient to be able and willing to fulfill all study requirements.
Who cannot join
- Patient has existing damage to the spinal column observed via MRI of spine that, in the opinion of the Investigator, would prevent intraspinal drug administration (e.g. cord compression from metastatic tumor that could obstruct catheter placement or drug flow). If the patient has a medical condition that contraindicates MRI, the investigator should proceed with the closest appropriate study (i.e. CT scan, X-ray) to rule out any spinal abnormalities that would prevent intraspinal drug administration.
- Patient has a systemic infection that, in the opinion of the investigator, contraindicates an implantable pump.
- Patient's anatomy is not large enough to accommodate the pump's size and weight.
- Patient is pregnant or breast-feeding or is of child-bearing potential and not employing effective birth control.
- Patient has known allergies or sensitivities to pump system materials (e.g., silicone rubber, titanium, polyphenylsulfone, acetal resin, polyvinylidene fluoride, tungsten).
- Patient has known allergies to morphine or would be contraindicated for morphine, based on the drug labeling.
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- Patient has a major coexisting medical condition (such as gastrointestinal problems, respiratory reserve / lung function problems, or heart conditions that cannot tolerate further lowering of blood pressure) that, in the opinion of the investigator, contraindicates an implantable pump.
- Patient will require MRI evaluation post-implantation.
- Patient has other implanted cardiac electronic devices.
- Patient has an occupation where he/she would be exposed to high current industrial equipment, powerful magnets or transmitting towers, such as, electricians, electrical engineers or MRI technicians.
- Patient is unable to participate in all necessary study activities due to physical or mental limitations.
- Patient is unable or unwilling to return for all required follow-up visits.
About this study
Intrathecal infusion pumps are increasingly used to deliver analgesics for chronic intractable pain. The PUMP II trial is designed to evaluate the ongoing safety and efficacy of the new Prometra® Programmable Pump System for intrathecal administration of morphine sulfate to treat chronic intractable pain.
Read the detailed description
The development of fully implantable systems changed the dynamics and risks associated with intrathecal drug delivery. Pump reservoirs could be refilled with medication more infrequently (every 1-3 months), greatly reducing the risk of infection. Pumps were initially driven by the pressure differential of an injected gas, pushing drug at a fixed rate from an isolated chamber through an orifice of predetermined size. Later, mechanical pumps were developed that allowed for programmability of different infusion rates, and complex administration of infusions and preset boluses. These pumps have dominated the US market for long-term intrathecal drug delivery systems (IDDSs), and have expanded the range of conditions and patients that can be treated successfully.
Because IDDSs characteristically deliver low flow rates of drug to the intrathecal space (<1 mL/day), the reliability, durability, and accuracy of the pump are critical for the efficacy and safety of treatment. This continued access trial will assess the ongoing safety and efficacy of a new fully implanted IDDS, the Prometra Programmable Pump.
- Conditions
- Intractable Pain, Back Pain, Leg Pain, Arm Pain, Trunk Pain
- Being tested
- Prometra Programmable Pump
- Keywords
- back pain, intractable pain, implantable infusion pump, morphine
- Medical subject headings
- 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 PumpDevice
Implantation of Prometra Pump for delivery of intrathecal morphine for the treatment of chronic intractable pain
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intractable 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
- Expanded access
Sponsor and investigators
- Lead sponsor
- Flowonix Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00866164
- Sponsor's protocol ID
- G060192/S019
- Acronym
- (PUMP 2)
- Status last verified
- Mar 2012
- First submitted
- 18 Mar 2009
- Last updated
- 5 Mar 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prometra's Utilization in Mitigating Pain II
- ClinicalTrials.gov ID
- NCT00866164
- Acronym / sponsor ID
- (PUMP 2) / G060192/S019
- Conditions
- Intractable Pain, Back Pain, Leg Pain, Arm Pain, Trunk Pain
- Keywords
- back pain, intractable pain, implantable infusion pump, morphine
- Study type
- Expanded access
- Recruitment status
- Approved For Marketing
- Lead sponsor
- Flowonix MedicalIndustry (pharma, biotech, devices)
- First posted
- 20 Mar 2009 (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.
Intrathecal infusion pumps are increasingly used to deliver analgesics for chronic intractable pain. The PUMP II trial is designed to evaluate the ongoing safety and efficacy of the new Prometra® Programmable Pump System for intrathecal administration of morphine sulfate to treat chronic intractable pain.
Detailed description
The development of fully implantable systems changed the dynamics and risks associated with intrathecal drug delivery. Pump reservoirs could be refilled with medication more infrequently (every 1-3 months), greatly reducing the risk of infection. Pumps were initially driven by the pressure differential of an injected gas, pushing drug at a fixed rate from an isolated chamber through an orifice of predetermined size. Later, mechanical pumps were developed that allowed for programmability of different infusion rates, and complex administration of infusions and preset boluses. These pumps have dominated the US market for long-term intrathecal drug delivery systems (IDDSs), and have expanded the range of conditions and patients that can be treated successfully.
Because IDDSs characteristically deliver low flow rates of drug to the intrathecal space (<1 mL/day), the reliability, durability, and accuracy of the pump are critical for the efficacy and safety of treatment. This continued access trial will assess the ongoing safety and efficacy of a new fully implanted IDDS, the Prometra Programmable Pump.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patient is suffering from cancer pain requiring strong opioids (e.g., fentanyl, methadone, levorphanol, hydromorphone, oxymorphone, oxycodone) OR Patient has chronic, non-malignant pain OR Patient needs an implantable pump system (pump AND catheter) replaced due to malfunction or battery depletion. Patient must have documented history of sufficient pain relief with intrathecal morphine sulfate infusion.
- Patient is 18 years of age or older.
- Patient has life expectancy of > 6 months.
- Patient has documented failure to respond to less invasive methods of pain control, including attempts to eliminate physical and behavioral abnormalities that may cause an exaggerated reaction to pain.
- Patient has pain that is ineffectively controlled by single or multiple systemic (oral, rectal, transdermal or intravenous) analgesic treatments or patient experienced intolerable side effects from such treatment.
Key exclusion criteria (12 listed)
- Patient has existing damage to the spinal column observed via MRI of spine that, in the opinion of the Investigator, would prevent intraspinal drug administration (e.g. cord compression from metastatic tumor that could obstruct catheter placement or drug flow). If the patient has a medical condition that contraindicates MRI, the investigator should proceed with the closest appropriate study (i.e. CT scan, X-ray) to rule out any spinal abnormalities that would prevent intraspinal drug administration.
- Patient has a systemic infection that, in the opinion of the investigator, contraindicates an implantable pump.
- Patient's anatomy is not large enough to accommodate the pump's size and weight.
- Patient is pregnant or breast-feeding or is of child-bearing potential and not employing effective birth control.
- Patient has known allergies or sensitivities to pump system materials (e.g., silicone rubber, titanium, polyphenylsulfone, acetal resin, polyvinylidene fluoride, tungsten).
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 PumpImplantation of Prometra Pump for delivery of intrathecal morphine for the treatment of chronic intractable pain | Device | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2012.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Prometra Programmable Pump in people with Intractable Pain and Back Pain, run by Flowonix Medical.
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 10 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 5 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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.
Where can I read the original study information?
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 5 Mar 2012; AzTrials last refreshed its copy on 29 Oct 2026.