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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Infusion Pump (Prometra) | Device | Implantation of pump/catheter for infusion of morphine into the intrathecal space |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months - acute study |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pain Control Network | Louisville | Kentucky | 40205 | United States | ||
| Center for Pain Management |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Mean | 90% Confidence Interval | % of programmed vol. actually delivered | 6 months - acute study |
Up to 3 years and 7 months.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group 1 | Prometra Intrathecal Pump System |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Implant Site Infection | Infections and infestations | MedDRA |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trials Manager | Medasys, Inc. | 973-426-9229 | jarrambide@medasyspumps.com |
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| ID | Term |
|---|---|
| D010148 | Pain, Intractable |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D007260 | Infusion Pumps |
| ID | Term |
|---|---|
| D004864 | Equipment and Supplies |
| D001187 | Artificial Organs |
| D013523 | Surgical Equipment |
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| St Louis |
| Missouri |
| 63109 |
| United States |
| Forsyth Medical Center | Winston-Salem | North Carolina | 27103 | United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| ID | Title | Description |
|---|---|---|
| OG000 | Group 1 | Prometra Intrathecal Pump System |
|
|
| 11 |
| 110 |
| 110 |
| 110 |
| Diplegia (temporary) | Nervous system disorders | MedDRA |
|
| Drug Withdrawal Syndrome | General disorders |
|
| Extradural abscess | Infections and infestations |
|
| Hematoma | Vascular disorders |
|
| Implant Site Cellulitis | Infections and infestations |
|
| Leukocytosis | Blood and lymphatic system disorders |
|
| Nausea | Gastrointestinal disorders |
|
| Post Lumbar Puncture Syndrome | Injury, poisoning and procedural complications |
|
| Procedural Pain | Injury, poisoning and procedural complications |
|
| Surgery to replace pump | Surgical and medical procedures |
|
| Vomiting | Gastrointestinal disorders |
|
| Vomiting | Gastrointestinal disorders |
|
| Implant Site Pain | General disorders |
|
| Implant Site Edema | General disorders |
|
| Implant Site Erythema | General disorders |
|
| Pain | General disorders |
|
| Incision Site Infection | Infections and infestations |
|
| Procedural Pain | Injury, poisoning and procedural complications |
|
| Wound secretion | Injury, poisoning and procedural complications |
|
| Post Lumbar Puncture Syndrome | Injury, poisoning and procedural complications |
|
| Seroma | Injury, poisoning and procedural complications |
|
| Headache | Nervous system disorders |
|
| Surgery (device-related) | Surgical and medical procedures |
|
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