Intractable Pain
Conditions
Brief summary
Clinical evaluation of the safety and efficacy of the Prometra Programmable Infusion Pump to accurately supply drug to the intrathecal space for the treatment of chronic pain.
Detailed description
Chronic conditions of pain and spasticity are and have been major challenges to traditional medical treatment. Chronic pain and spasticity seriously reduce the quality of life and restrict normal daily activities for many people. The first line of defense is normally oral medications. However, a significant number of these patients require additional or alternative therapy due to the side effects of the oral medications or the intractable nature of the condition. In 1979, Wand et. al. found that small amounts of morphine, when injected into the sub-arachnoid space, had significant affect in reducing pain. Since that time a number of drug products and infusion pumps have been developed to address this condition. The primary drug used for this purpose in preservative-free morphine sulfate solution which is delivered via an implanted intrathecal catheter. The Prometra Intrathecal Pump System is only the second programmable pump to be used in the treatment of chronic pain.
Interventions
DEVICEInfusion Pump (Prometra)
Implantation of pump/catheter for infusion of morphine into the intrathecal space
Sponsors
Flowonix Medical
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* suffering from chronic pain * 18 years of age or older * life expectancy \>6 months * failure to respond to less invasive methods * patient undergone successful morphine trial * patient agrees with Protocol requirements * patient considered good subject per clinician
Exclusion criteria
* Existing spinal problems that prevent treatment * systemic infection * patient is pregnant or breast feeding * known allergy or sensitivity to materials * coexisting medical condition that precludes pump usage * subject requires MRI post procedure * subject unwilling/unable to comply
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Demonstrate That Prometra Programmable Pump System Accurately and Safely Delivers Medication in the Intrathecal Space, as Programmed. | 6 months - acute study | Accuracy was determined by calculation of the delivered to programmed drug volume (DP) ratio. The DP ratio was calculated as the ratio of delivered drug volume (the volumetrically determined delivered drug volume) to the programmed drug volume (the volume of drug that was programmed to be delivered) summed cumulatively for all fill/refills, including any unscheduled visits per patient. The delivered drug volume over all (scheduled and unscheduled) valid fill/refill sessions was summed together per patient as the numerator and the programmed drug volume over all valid fill/refill sessions was summed together per patient as the denominator to provide a per-patient DP ratio. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Prometra Intrathecal Pump System This group was treated with an intrathecal pump implant. Pumps were filled with morphine sulfate. Dosage, concentration, and other programmable parameters were prescribed at the discretion of the physician. | 110 |
| Total | 110 |
Baseline characteristics
| Characteristic | Prometra Intrathecal Pump System |
|---|---|
| Age Continuous | 56 years STANDARD_DEVIATION 13 |
| Sex: Female, Male Female | 51 Participants |
| Sex: Female, Male Male | 59 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 110 / 110 |
| serious Total, serious adverse events | 11 / 110 |
Outcome results
Primary
Demonstrate That Prometra Programmable Pump System Accurately and Safely Delivers Medication in the Intrathecal Space, as Programmed.
Accuracy was determined by calculation of the delivered to programmed drug volume (DP) ratio. The DP ratio was calculated as the ratio of delivered drug volume (the volumetrically determined delivered drug volume) to the programmed drug volume (the volume of drug that was programmed to be delivered) summed cumulatively for all fill/refills, including any unscheduled visits per patient. The delivered drug volume over all (scheduled and unscheduled) valid fill/refill sessions was summed together per patient as the numerator and the programmed drug volume over all valid fill/refill sessions was summed together per patient as the denominator to provide a per-patient DP ratio.
Time frame: 6 months - acute study
Population: Sample size was based on previous testing and data from similar devices. With a population of 60 subjects the 90% CI would be 95 ± 7, or 0.88 to 1.02. Therefore, approximately 60 patients with 6-months of data will provide adequate data to demonstrate accuracy, although up to 110 patients may be implanted to account for patient drop-outs.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Group 1 | Demonstrate That Prometra Programmable Pump System Accurately and Safely Delivers Medication in the Intrathecal Space, as Programmed. | 97.8 % of programmed vol. actually delivered |