Clinical trial NCT04312685: Transitioning to a Valve -Gated Intrathecal Drug Delivery System
Official title: Transitioning to a Valve -Gated Intrathecal Drug Delivery System (IDDS): An Open-Label, Non-Randomized, Single-Blind, Multi-Center Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pain
Pain, Chronic
Pain, Intractable
Pain, Back
Keywords: IDDS
Intrathecal drug therapy
pain pump
Lead sponsor: Bux, Anjum, MD
Sponsor class: OTHER
Collaborators: name: Flowonix Medical
First posted: 2020-03-18
Enrollment: 120
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Open-Label, Non-Randomized, Single-Blind, Multi-Center
Primary purpose: TREATMENT

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 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).

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 potential to bias when informed they will get less drug with the new pump than they were receiving in the old pump this could subjectively affect pain scores as well. After valve-gated pump implant and dose reduction, the appropriate pain therapy will be provided to adequately address pain management in the opinion of the study investigator using standard of care processes and VAS scores.

Once subjects have been implanted with the valve-gated pump they will be started on a minimum 20% dose reduction (same medications and concentrations prior to explant). If at any time during the subjects' treatment it is determined by the investigator that the subjects' treatment dose needs to be increased, the dose can be increased in increments not to exceed 5% (no change to concentration) based on VAS scores at current and last visits.

Eligibility criteria: 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

Primary outcomes:
measure: Reduced pain medication through Prometra Implantable Pump System
timeFrame: 12 months
Secondary outcomes:
measure: Visual Analog Scale for Pain changes
timeFrame: 12 months
measure: Owestry Disability Index changes
timeFrame: 12 months
measure: Global Pain Scale Assessments
timeFrame: 12 months
Other outcomes:
Locations:
city: Idaho Falls
country: United States
facility: Pain and Spine Specialists
state: Idaho
city: Overland Park
country: United States
facility: Crimson Pain Management
state: Kansas
city: Lexington
country: United States
facility: Bux Pain Management
state: Kentucky
city: Slidell
country: United States
facility: Aust Interventional Pain
state: Louisiana
city: Southfield
country: United States
facility: Michigan Head & Spine Institute
state: Michigan
city: Turnersville
country: United States
facility: National Spine & Pain Center
state: New Jersey
city: Rochester
country: United States
facility: The Spine Center at Ridgeway
state: New York
city: Chattanooga
country: United States
facility: Consultants in Pain Management
state: Tennessee
Study officials:
affiliation: Owner
name: Anjum Bux, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Hayek SM, Deer TR, Pope JE, Panchal SJ, Patel VB. Intrathecal therapy for cancer and non-cancer pain. Pain Physician. 2011 May-Jun;14(3):219-48.
citation: Hayek SM, Veizi E, Hanes M. Intrathecal Hydromorphone and Bupivacaine Combination Therapy for Post-Laminectomy Syndrome Optimized with Patient-Activated Bolus Device. Pain Med. 2016 Mar;17(3):561-571. doi: 10.1093/pm/pnv021. Epub 2015 Dec 14.
citation: Konrad PE, Huffman JM, Stearns LM, Plunkett RJ, Grigsby EJ, Stromberg EK, Roediger MP, Wells MD, Weaver TW. Intrathecal Drug Delivery Systems (IDDS): The Implantable Systems Performance Registry (ISPR). Neuromodulation. 2016 Dec;19(8):848-856. doi: 10.1111/ner.12524. Epub 2016 Oct 12.
citation: Tangen KM, Leval R, Mehta AI, Linninger AA. Computational and In Vitro Experimental Investigation of Intrathecal Drug Distribution: Parametric Study of the Effect of Injection Volume, Cerebrospinal Fluid Pulsatility, and Drug Uptake. Anesth Analg. 2017 May;124(5):1686-1696. doi: 10.1213/ANE.0000000000002011.