Infusion Pump (Prometra)
DeviceImplantation of pump/catheter for infusion of morphine into the intrathecal space
Other names: Prometra
NCT Number: NCT00817596
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.
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Not applicable
Pain Control Network, Louisville, Kentucky, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Implantation of pump/catheter for infusion of morphine into the intrathecal space
Other names: Prometra
Time frame: 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.
Flowonix Medical
Industry
Acronym: PUMP
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT04909593
Back Pain, Chronic Pain
Greenville, South Carolina, United States
View Trial DetailsNCT01567345
Advanced Cancer, Agnosia
Angers, France
View Trial DetailsNCT01854229
Back Pain, Cancer Pain
La Jolla, California, United States
View Trial DetailsNCT03082261
Chronic Pain, Intractable Pain
Phoenix, Arizona, United States
View Trial Details