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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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
No Placebo-Only Group
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
- Cancer
- Back Pain
- Pain
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Reduced pain medication through Prometra Implantable Pump System
Secondary study objectives
Global Pain Scale Assessments
Owestry Disability Index changes
Visual Analog Scale for Pain changes
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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 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 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