Status:
UNKNOWN
Transitioning to a Valve -Gated Intrathecal Drug Delivery System
Lead Sponsor:
Bux, Anjum, MD
Collaborating Sponsors:
Flowonix Medical
Conditions:
Pain
Pain, Chronic
Eligibility:
All Genders
21+ years
Phase:
NA
Brief Summary
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 w...
Detailed Description
This study will employ a single-blind where study participants will not be told about the dose reduction of at least 20% when the valve-gated pump is implanted. A study participant has a significant p...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 27 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 30 2023
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT04312685
Start Date
July 27 2020
End Date
November 30 2023
Last Update
July 7 2021
Active Locations (8)
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1
Pain and Spine Specialists
Idaho Falls, Idaho, United States, 83404
2
Crimson Pain Management
Overland Park, Kansas, United States, 66209
3
Bux Pain Management
Lexington, Kentucky, United States, 40509
4
Aust Interventional Pain
Slidell, Louisiana, United States, 70458