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Programmable Pump System

Prometra II Programmable Pump system for Chronic Pain (TRANSIT Trial)

N/A
Waitlist Available
Led By Anjum Bux, MD
Research Sponsored by Bux, Anjum, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Active existing peristaltic intrathecal drug delivery system (IDDS)
Minimum of 3 months of information from the following: VAS, ODI, Global Pain Scale, Pump refill printouts (dosage and concentration), Other Interventions for pain (injections, nerve blocks, etc.), Estimated Replacement Indicator (ERI) printout required showing < 12 months of battery life, Catheter Access Procedure (CAP) study performed to document patency of catheter, if not replacing
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

TRANSIT Trial Summary

This trial is testing a new pump to see if it requires less drug to manage pain than the old pump.

Eligible Conditions
  • Chronic Pain
  • Pain
  • Back Pain

TRANSIT Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You currently have a device for delivering medication into your spinal fluid.
Select...
You need to have at least 3 months of information about your pain levels, other treatments you've tried, and the status of your pain pump or catheter.
Select...
You have a long-lasting, severe pain condition that is not related to cancer.

TRANSIT Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Reduced pain medication through Prometra Implantable Pump System
Secondary outcome measures
Global Pain Scale Assessments
Owestry Disability Index changes
Visual Analog Scale for Pain changes

TRANSIT Trial Design

2Treatment groups
Active Control
Group I: Prometra Programmable PumpActive Control1 Intervention
Pain scores and drug doses will be prospectively collected for valve-gated Prometra® Programmable Pump system(Flowonix Medical)' at (refills 1-3) and will be compared to 3 months retrospectively collected pain scores (VAS, ODI and Global Pain Scale Assessments) and drug doses prior to peristaltic pump explant.
Group II: Retrospective records for peristaltic pumpActive Control1 Intervention
Prior pain scores and drug doses from the patients who need a new valve gated pump will be recorded and used for comparison after it is changed.

Find a Location

Who is running the clinical trial?

Bux, Anjum, MDLead Sponsor
Flowonix MedicalIndustry Sponsor
8 Previous Clinical Trials
675 Total Patients Enrolled
3 Trials studying Chronic Pain
473 Patients Enrolled for Chronic Pain
Anjum Bux, MDPrincipal InvestigatorOwner

Media Library

Prometra II Programmable Pump system - Flowonix Medical (Programmable Pump System) Clinical Trial Eligibility Overview. Trial Name: NCT04312685 — N/A
Chronic Pain Research Study Groups: Prometra Programmable Pump, Retrospective records for peristaltic pump
Chronic Pain Clinical Trial 2023: Prometra II Programmable Pump system - Flowonix Medical Highlights & Side Effects. Trial Name: NCT04312685 — N/A
Prometra II Programmable Pump system - Flowonix Medical (Programmable Pump System) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04312685 — N/A
Chronic Pain Patient Testimony for trial: Trial Name: NCT04312685 — N/A

Frequently Asked Questions

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

Are there opportunities to join this experiment at present?

"Data on clinicaltrials.gov does not indicate that this trial is actively recruiting any more, as the last update was made on July 2nd 2021 and it first opened to recruitment in 2020. Nevertheless, there are 1001 other trials seeking participants at present."

Answered by AI

How many sites are participating in this trial's implementation?

"The Spine Center at Ridgeway in Rochester, New york, Pain and Spine Specialists in Idaho Falls, Idaho, National Spine & Pain Centre in Turnersville, New jersey, plus 8 other medical sites are participating."

Answered by AI

Who else is applying?

What state do they live in?
Louisiana
Tennessee
How old are they?
65+
What site did they apply to?
Aust Interventional Pain
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
3+

Why did patients apply to this trial?

I have tried medications and chiropractors and exercises and nothing has helped. It’s affecting the quality of my life.
PatientReceived no prior treatments
Recent research and studies
~26 spots leftby Mar 2025