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Programmable Intrathecal Infusion Pump

Prospective pump candidates for Chronic Pain

N/A
Waitlist Available
Research Sponsored by Flowonix Medical
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up five years
Awards & highlights

Study Summary

This trial will help to assess the long-term safety of the Prometra Pump, a device used to treat pain.

Eligible Conditions
  • Chronic Pain
  • Cancer Pain
  • Back Pain

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~five years
This trial's timeline: 3 weeks for screening, Varies for treatment, and five years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Rate of granuloma formation
Secondary outcome measures
Pump battery life
Pump failure
Other outcome measures
Device-related adverse events
Device-related serious adverse events
Granuloma formation by drug type
+1 more

Trial Design

2Treatment groups
Active Control
Group I: Prospective pump candidatesActive Control1 Intervention
New candidates who will receive the Prometra Programmable Intrathecal Infusion Pump
Group II: Previous IDE study subjects continuing with the therapyActive Control1 Intervention
Patients who were part of the previous IDE study, still have an active Prometra Programmable Intrathecal Infusion Pump, and are willing to continue in a study protocol.

Find a Location

Who is running the clinical trial?

Flowonix MedicalLead Sponsor
8 Previous Clinical Trials
395 Total Patients Enrolled
3 Trials studying Chronic Pain
193 Patients Enrolled for Chronic Pain
Duane DeyStudy DirectorFlowonix Medical
Cory BrantleyStudy DirectorFlowonix Medical

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who else is applying?

What state do they live in?
North Carolina
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Prometra Post-Approval Study
2013. "Prometra Post-Approval Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01854229.
~34 spots leftby Apr 2025
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