Prometra's Utilization in Mitigating Pain II ((PUMP 2))

March 2, 2012 updated by: Flowonix Medical
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.

Study Overview

Status

Approved for marketing

Intervention / Treatment

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 Type

Expanded Access

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

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. 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.
  2. Patient is 18 years of age or older.
  3. Patient has life expectancy of > 6 months.
  4. 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.
  5. 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.
  6. Patient has had a successful trial of morphine sulfate (intrathecal or epidural) for relief of the target symptoms.
  7. Patient agrees to obtain pain medication prescriptions only from the investigator.
  8. Patient has provided written informed consent to participate in the study.
  9. Patient is considered by the investigator to be a medically and psychologically appropriate candidate for pump implantation.
  10. Investigator and/or study coordinator considers the patient to be able and willing to fulfill all study requirements.

Exclusion Criteria:

  1. 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.
  2. Patient has a systemic infection that, in the opinion of the investigator, contraindicates an implantable pump.
  3. Patient's anatomy is not large enough to accommodate the pump's size and weight.
  4. Patient is pregnant or breast-feeding or is of child-bearing potential and not employing effective birth control.
  5. Patient has known allergies or sensitivities to pump system materials (e.g., silicone rubber, titanium, polyphenylsulfone, acetal resin, polyvinylidene fluoride, tungsten).
  6. Patient has known allergies to morphine or would be contraindicated for morphine, based on the drug labeling.
  7. 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.
  8. Patient will require MRI evaluation post-implantation.
  9. Patient has other implanted cardiac electronic devices.
  10. 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.
  11. Patient is unable to participate in all necessary study activities due to physical or mental limitations.
  12. Patient is unable or unwilling to return for all required follow-up visits.

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?

Collaborators and Investigators

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

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 Registration Dates

First Submitted

March 18, 2009

First Submitted That Met QC Criteria

March 18, 2009

First Posted (Estimate)

March 20, 2009

Study Record Updates

Last Update Posted (Estimate)

March 5, 2012

Last Update Submitted That Met QC Criteria

March 2, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Other Study ID Numbers

  • G060192/S019

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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