NCT03876158

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

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

• Status: Withdrawn
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Rush University Medical Center · Academic / Other
• Sex: All
• Age: 22 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

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

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).

Conditions

• Chronic Pain
• Intractable Pain
• Back Pain

Interventions

Type	Name	Description
DEVICE	Prometra II Programmable Pump system(Flowonix Medical)	This valve gated Prometra II Programmable Pump system will be replacing prior peristaltic Synchromed II pump

Timeline

• Start date: 2019-10-01
• Primary completion: 2022-03-01
• Completion: 2022-06-01
• First posted: 2019-03-15
• Last updated: 2020-03-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study