Transitioning to a Valve -Gated Intrathecal Drug Delivery System (IDDS)

Study Overview
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Brief Summary
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Flowonix Prometra® II Programmable Pump may require a smaller dose of drug when converting from other commercially available intrathecal drug delivery systems (IDDS).

Detailed Description
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This open-label, non-randomized, single-blind, multi-center study is designed to evaluate effects of a planned 20% dose reduction when converting to valve-gated from a peristaltic pump. Study participants will be blinded (single blind) to the dose reduction aspect of this trial and must remain blinded to this dose reduction information throughout the trial in an attempt to provide an unbiased assessment of the pain encountered by the patient with their pain pump medications used. This study will compare the historical pain medication dose and pain scores using the peristaltic pump at baseline as well as from the last pump refill visit prior to explant to the prospective pain medication dose and pain scores using the valve-gated pump and collected at refill visits 1, 2 and 3 after valve-gated pump implant (but not exceed 12 months).

Official Title
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Transitioning to a Valve -Gated Intrathecal Drug Delivery System (IDDS): An Open-Label, Non-Randomized, Single-Blind, Multi-Center, Cross-Over Study (TRANSIT)

Conditions
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Chronic Pain, Intractable Pain, Back Pain

Intervention / Treatment
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* Device: Prometra II Programmable Pump system(Flowonix Medical)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Be male or female between the ages of 22 and 85 years Be capable of giving informed consent and completing assessments required by the study Have pain intensity of greater than 5 out of 10 as measured by VAS Have an active existing peristaltic intrathecal drug delivery system Have stable drug dosage for at least 6 weeks prior to valve-gated pump implant Be an appropriate candidate for surgery Be able to comply with required study visits and assessments including English proficiency Exclusion Criteria: Have a significant pain disorder not intended to be treated with the test device or comparator Be terminally ill and/or have a life expectancy of less than 6 months Be a pregnant/lactating woman or a woman of child-bearing potential Have a systemic or local infection (contraindicated for pump implantation) Have history/evidence of an active disruptive psychiatric disorder or other known condition with potential to impact compliance with study visits and assessments Have an underlying condition increasing susceptibility to infection

Ages Eligible for Study
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Minimum Age: 22 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Prior Peristaltic Synchromed II intrathecal pump's data prior to crossover to valve-gated Flowonix Prometra® II Programmable Pump is recorded to compare.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Prometra® Programmable Pump<br>Pain scores and drug doses will be prospectively collected for valve-gated Prometra® Programmable Pump system(Flowonix Medical)' at (refill #1, refill #2, refill #3) and will be compared to retrospectively collected pain (VAS) scores and drug doses from the last refill prior to peristaltic pump explant. | Device: Prometra II Programmable Pump system(Flowonix Medical)<br>* This valve gated Prometra II Programmable Pump system will be replacing prior peristaltic Synchromed II pump<br>* Other names: Prior peristaltic Synchromed II pump;|
| Other: Prior records for peristaltic pump<br>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. | Device: Prometra II Programmable Pump system(Flowonix Medical)<br>* This valve gated Prometra II Programmable Pump system will be replacing prior peristaltic Synchromed II pump<br>* Other names: Prior peristaltic Synchromed II pump;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduced pain medication through Prometra Implantable Pump System | Total consumption of Pain medication both oral and intra thecal would also be recorded to show change in pain medication. | 12 months from Implant | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in pain score: Visual Analog Scale for Pain | Visual Analog Scale for Pain is being used assess the pain throughout the 12 month which shows No pain at one end to Pain as bad as it could be at other end. | 12 months from Implant |