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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 belowSelect...
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
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.
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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
Eligibility Criteria:
This trial includes the following eligibility criteria:- A procedure to check if the catheter is open and working properly, if not replacing.You have received other treatments for pain, like injections or nerve blocks.You need to have at least 3 months of information from various pain assessment tools and treatment records.You need to show a printout indicating that the device's battery will last for less than 12 months.You are suitable for surgery.You have any medical conditions that are listed as not safe for the Prometra medication.You need to provide a printout showing that the implantable device's battery has less than 12 months of life left.You have a serious pain condition that is not meant to be treated with the test device or the comparison treatment.You have advanced cancer and are not expected to live more than 12 months, according to the doctor.I am at least 21 years of age or older.ation
The patient must take a stable IDDS dosage and concentration for at least 6 weeks prior to valve-gated pump implantation.You have an infection anywhere in your body.You currently have a device for delivering medication into your spinal fluid.You have a long-term, severe pain condition that is not caused by cancer.You are currently using a device that delivers medication into your spinal canal.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.You have a long-lasting, severe pain condition that is not related to cancer.
Research Study Groups:
This trial has the following groups:- Group 1: Prometra Programmable Pump
- Group 2: Retrospective records for peristaltic pump
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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
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