N/A
N=110
Prometra's Utilization in Mitigating Pain (PUMP)
Intractable Pain
Bottom Line
View on ClinicalTrials.gov: NCT00817596 ↗Enrolled (actual)
110
Serious AEs
10.0%
Results posted
Jul 2012
Primary outcome: Primary: Demonstrate That Prometra Programmable Pump System Accurately and Safely Delivers Medication in the Intrathecal Space, as Programmed. — 97.8 % of programmed vol. actually delivered
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Infusion Pump (Prometra) (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Flowonix Medical
- Primary completion
- Mar 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Demonstrate That Prometra Programmable Pump System Accurately and Safely Delivers Medication in the Intrathecal Space, as Programmed. |
97.8 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00817596). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.