Transitioning to a Valve -Gated Intrathecal Drug Delivery System (IDDS)
WithdrawnPhase 4NCT03876158
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
Flowonix Prometra® II Programmable Pump may require a smaller dose of drug when converting from other commercially available intrathecal drug delivery systems (IDDS).
Study details
- Official title
- Transitioning to a Valve -Gated Intrathecal Drug Delivery System (IDDS): An Open-Label, Non-Randomized, Single-Blind, Multi-Center, Cross-Over Study (TRANSIT)
- Conditions
- Chronic Pain
- Intractable Pain
- Back Pain
- Interventions
- Device: Prometra II Programmable Pump system(Flowonix Medical)
- Sponsor
- Rush University Medical Center
- Collaborators
- Flowonix Medical
- Start date
- 2019-10
- Primary completion
- 2022-03
- Sex
- All
- Age range
- from 22 Years to 85 Years
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: 1. Be male or female between the ages of 22 and 85 years 2. Be capable of giving informed consent and completing assessments required by the study 3. Have pain intensity of greater than 5 out of 10 as measured by VAS 4. Have an active existing peristaltic intrathecal drug delivery system 5. Have stable drug dosage for at least 6 weeks prior to valve-gated pump implant 6. Be an appropriate candidate for surgery 7. Be able to comply with required study visits and assessments including English proficiency Exclusion Criteria: 1. Have a significant pain disorder not intended to be treated with the test device or comparator 2. Be terminally ill and/or have a life expectancy of less than 6 months 3. Be a pregnant/lactating woman or a woman of child-bearing potential 4. Have a systemic or local infection (contraindicated for pump implantation) 5. Have history/evidence of an active disruptive psychiatric disorder or other known condition with potential to impact compliance with study visits and assessments 6. Have an underlying condition increasing susceptibility to infection
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT03876158