- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00866164
Prometra's Utilization in Mitigating Pain II ((PUMP 2))
Study Overview
Status
Conditions
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
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
- 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.
Exclusion Criteria:
- 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.
- 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.
Study Plan
How is the study designed?
Collaborators and Investigators
Sponsor
Study record dates
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
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.
Clinical Trials on Back Pain
-
Dow University of Health SciencesRecruitingLow Back Pain | Chronic Low-back Pain | Low Back Pain, Mechanical | Mechanical Low Back Pain | Pain, Chronic | Pain, Back | Lower Back Pain Chronic | CLBP - Chronic Low Back PainPakistan
-
Faculdade de Ciências Médicas da Santa Casa de...CompletedLow Back Pain, Mechanical | Low Back Pain, Postural | Lower Back Pain Chronic | Low Back Pain, Posterior CompartmentBrazil
-
University of Colorado, BoulderNational Institutes of Health (NIH); Radiological Society of North America; Psychophysiologic... and other collaboratorsCompletedChronic Pain | Back Pain Lower Back Chronic | Back Pain, LowUnited States
-
Federal University of Minas GeraisRecruitingBack Pain | Low Back Pain | Chronic Low-back Pain | Back Pain Lower Back ChronicBrazil
-
Marco LoggiaNational Institute of Neurological Disorders and Stroke (NINDS)Active, not recruitingLow Back Pain | Pain, Chronic | Back Pain Lower Back Chronic | Back Pain With Radiation | Back Pain Without Radiation | Back AcheUnited States
-
Carilion ClinicVirginia Center for Health InnovationEnrolling by invitationBack Pain | Back Pain Lower Back Chronic | Back Pain, LowUnited States
-
Dan RhonNational Center for Complementary and Integrative Health (NCCIH); 59th Medical... and other collaboratorsRecruitingLow Back Pain | Chronic Pain | Surgery | Back Pain Lower Back Chronic | Back Pain, LowUnited States
-
Balgrist University HospitalUniversity of Zurich, Epidemiology, Biostatistics and Prevention InstituteCompletedBack Pain | Back Pain With Radiation | Back Pain, LowSwitzerland
-
Vanderbilt University Medical CenterWithdrawnBack Pain, Low | Back Pain Without RadiationUnited States
-
Columbia UniversityUpright Technologies Ltd.CompletedLower Back Pain | Back Pain | Postural Low Back PainUnited States
Clinical Trials on Prometra Programmable Pump
-
Bux, Anjum, MDFlowonix MedicalEnrolling by invitationPain | Pain, Chronic | Pain, Intractable | Pain, BackUnited States
-
Rush University Medical CenterFlowonix MedicalWithdrawnBack Pain | Chronic Pain | Intractable PainUnited States
-
Culicchia Neurological ClinicFlowonix MedicalRecruitingTraumatic Brain Injury | Muscle Spasticity | CVA (Cerebrovascular Accident) | Cerebral Palsy, Spastic | MS (Multiple Sclerosis) | Injuries, Spinal CordUnited States
-
Flowonix MedicalCompletedBack Pain | Chronic Pain | Cancer Pain | Intractable PainUnited States
-
Flowonix MedicalWithdrawn
-
Flowonix MedicalCompleted
-
Codman & ShurtleffTerminated
-
Institut Cancerologie de l'OuestCompletedAdvanced Cancer | Intractable PainFrance
-
Flowonix MedicalWithdrawnPain Management | Cancer PainUnited States