Transitioning to a Valve -Gated Intrathecal Drug Delivery System
Unknown statusNot applicableNCT04312685
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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)
This study is designed to explore if the valve-gated pump requires less drug to manage subject pain than the prior standard peristaltic pump in the same subject. The newly implanted valve-gated pump will be programmed to deliver a minimum dose reduction of 20% of the same medication that was delivered in the peristaltic pump prior to explant. The drug therapy will be evaluated and pain scores will be evaluated over time (3 refill cycles prospectively for the valve-gated pump and 6 months retrospectively for the peristaltic pump).
Study details
- Official title
- Transitioning to a Valve -Gated Intrathecal Drug Delivery System (IDDS): An Open-Label, Non-Randomized, Single-Blind, Multi-Center Study
- Interventions
- Device: Prometra II Programmable Pump system - Flowonix Medical
- Sponsor
- Bux, Anjum, MD
- Collaborators
- Flowonix Medical
- Start date
- 2020-07-27
- Primary completion
- 2023-04-01
- Sex
- All
- Age range
- from 21 Years
- Healthy volunteers
- true
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 8
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: Subjects meeting all of the following criteria will be eligible for enrollment in the study: * 21 years of age or older * Provide written informed consent for study participation * Active existing peristaltic intrathecal drug delivery system (IDDS) * Stable IDDS dosage and concentration for at least 6 weeks prior to valve-gated pump implant * Minimum of 3 months of information from the following: * VAS, ODI, Global Pain Scale * Pump refill printouts (dosage and concentration) * Other Interventions for pain (injections, nerve blocks, etc.) * Estimated Replacement Indicator (ERI) printout required showing \< 12 months of battery life * Catheter Access Procedure (CAP) study performed to document patency of catheter, if not replacing * Diagnosis of nonmalignant, chronic intractable pain as documented in medical history * Appropriate candidate for surgery * Able to comply with study requirements including visits and assessments, in the opinion of the investigator Exclusion Criteria: Subjects meeting any of the following criteria will be excluded from participating in the study: * Any contraindications listed in the Prometra labeling * Significant pain disorder not intended to be treated with the test device or comparator * Terminally ill, malignant cancer diagnosis and/or has a life expectancy of less than 12 months in the opinion of the investigator * Pregnant/lactating woman or is of child-bearing potential and not utilizing effective birth control. * Systemic or local infection (contraindicated for pump implantation) * History/evidence of an active disruptive psychiatric disorder or other known condition with potential to impact compliance with study visits and assessments, in the investigator's opinion
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT04312685