Trial Outcomes & Findings for Prometra's Utilization in Mitigating Pain (PUMP) (NCT NCT00817596)

Last Updated: 2012-08-17

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

110 participants

Primary outcome timeframe

6 months - acute study

Results posted on

2012-08-17

Participant Flow

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	110
Overall Study COMPLETED	62
Overall Study NOT COMPLETED	48

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Prometra's Utilization in Mitigating Pain (PUMP)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Prometra Intrathecal Pump System n=110 Participants 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.
Age Continuous	56 years STANDARD_DEVIATION 13 • n=5 Participants
Sex: Female, Male Female	51 Participants n=5 Participants
Sex: Female, Male Male	59 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Group 1 n=110 Participants Prometra Intrathecal Pump System
Demonstrate That Prometra Programmable Pump System Accurately and Safely Delivers Medication in the Intrathecal Space, as Programmed.	97.8 % of programmed vol. actually delivered Interval 97.4 to 98.3

Adverse Events

Group 1

Serious events: 11 serious events

Other events: 110 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Group 1 n=110 participants at risk Prometra Intrathecal Pump System
Infections and infestations Implant Site Infection	2.7% 3/110 • Number of events 3 • Up to 3 years and 7 months.
Nervous system disorders Diplegia (temporary)	0.91% 1/110 • Number of events 1 • Up to 3 years and 7 months.
General disorders Drug Withdrawal Syndrome	0.91% 1/110 • Number of events 1 • Up to 3 years and 7 months.
Infections and infestations Extradural abscess	0.91% 1/110 • Number of events 1 • Up to 3 years and 7 months.
Vascular disorders Hematoma	0.91% 1/110 • Number of events 1 • Up to 3 years and 7 months.
Infections and infestations Implant Site Cellulitis	0.91% 1/110 • Number of events 1 • Up to 3 years and 7 months.
Blood and lymphatic system disorders Leukocytosis	0.91% 1/110 • Number of events 1 • Up to 3 years and 7 months.
Gastrointestinal disorders Nausea	0.91% 1/110 • Number of events 1 • Up to 3 years and 7 months.
Injury, poisoning and procedural complications Post Lumbar Puncture Syndrome	0.91% 1/110 • Number of events 1 • Up to 3 years and 7 months.
Injury, poisoning and procedural complications Procedural Pain	0.91% 1/110 • Number of events 1 • Up to 3 years and 7 months.
Surgical and medical procedures Surgery to replace pump	0.91% 1/110 • Number of events 1 • Up to 3 years and 7 months.
Gastrointestinal disorders Vomiting	0.91% 1/110 • Number of events 1 • Up to 3 years and 7 months.

Other adverse events

Other adverse events
Measure	Group 1 n=110 participants at risk Prometra Intrathecal Pump System
Gastrointestinal disorders Nausea	13.6% 15/110 • Number of events 18 • Up to 3 years and 7 months.
Gastrointestinal disorders Vomiting	7.3% 8/110 • Number of events 9 • Up to 3 years and 7 months.
General disorders Implant Site Pain	21.8% 24/110 • Number of events 27 • Up to 3 years and 7 months.
General disorders Implant Site Edema	10.0% 11/110 • Number of events 15 • Up to 3 years and 7 months.
General disorders Implant Site Erythema	10.0% 11/110 • Number of events 11 • Up to 3 years and 7 months.
General disorders Pain	6.4% 7/110 • Number of events 9 • Up to 3 years and 7 months.
Infections and infestations Incision Site Infection	5.5% 6/110 • Number of events 7 • Up to 3 years and 7 months.
Injury, poisoning and procedural complications Procedural Pain	33.6% 37/110 • Number of events 39 • Up to 3 years and 7 months.
Injury, poisoning and procedural complications Wound secretion	8.2% 9/110 • Number of events 13 • Up to 3 years and 7 months.
Injury, poisoning and procedural complications Post Lumbar Puncture Syndrome	7.3% 8/110 • Number of events 10 • Up to 3 years and 7 months.
Injury, poisoning and procedural complications Seroma	5.5% 6/110 • Number of events 7 • Up to 3 years and 7 months.
Nervous system disorders Headache	8.2% 9/110 • Number of events 9 • Up to 3 years and 7 months.
Surgical and medical procedures Surgery (device-related)	11.8% 13/110 • Number of events 14 • Up to 3 years and 7 months.

Additional Information

Clinical Trials Manager

Medasys, Inc.

Phone: 973-426-9229

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60