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

Withdrawn before enrolling · Phase 4

Conditions studied: Chronic Pain, Intractable Pain, Back Pain

In brief

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

Key facts

Study ID

NCT03876158

Run by

Rush University Medical Center

People needed

0

Starts

2019-10-01

Expected to finish

2022-06-01

Last updated by the study team

2020-03-12

Who can join

Age: 22 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Rush University Medical Center Pain Center — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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