Status:
WITHDRAWN
Transitioning to a Valve -Gated Intrathecal Drug Delivery System (IDDS)
Lead Sponsor:
Rush University Medical Center
Collaborating Sponsors:
Flowonix Medical
Conditions:
Chronic Pain
Intractable Pain
Eligibility:
All Genders
22-85 years
Phase:
PHASE4
Brief 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 particip...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2022
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03876158
Start Date
October 1 2019
End Date
June 1 2022
Last Update
March 12 2020
Active Locations (1)
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1
Rush University Medical Center Pain Center
Chicago, Illinois, United States, 60612