Transitioning to a Valve -Gated Intrathecal Drug Delivery System (TRANSIT)

Transitioning to a Valve -Gated Intrathecal Drug Delivery System (IDDS): An Open-Label, Non-Randomized, Single-Blind, Multi-Center Study

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 Overview

• Status: Enrolling by invitation
• Conditions: Pain; Pain, Chronic; Pain, Intractable; Pain, Back
• Intervention / Treatment: Device: Prometra II Programmable Pump system - Flowonix Medical

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.

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Idaho
    • Idaho Falls, Idaho, United States, 83404
      • Pain and Spine Specialists
  • Kansas
    • Overland Park, Kansas, United States, 66209
      • Crimson Pain Management
  • Kentucky
    • Lexington, Kentucky, United States, 40509
      • Bux Pain Management
  • Louisiana
    • Slidell, Louisiana, United States, 70458
      • Aust Interventional Pain
  • Michigan
    • Southfield, Michigan, United States, 48034
      • Michigan Head & Spine Institute
  • New Jersey
    • Turnersville, New Jersey, United States, 08012
      • National Spine & Pain Center
  • New York
    • Rochester, New York, United States, 14626
      • The Spine Center at Ridgeway
  • Tennessee
    • Chattanooga, Tennessee, United States, 37421
      • Consultants in Pain Management

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Prometra Programmable Pump; Pain scores and drug doses will be prospectively collected for valve-gated Prometra® Programmable Pump system(Flowonix Medical)' at (refills 1-3) and will be compared to 3 months retrospectively collected pain scores (VAS, ODI and Global Pain Scale Assessments) and drug doses prior to peristaltic pump explant.	Device: Prometra II Programmable Pump system - Flowonix Medical; This valve gated Prometra II Programmable Pump system will be replacing prior peristaltic Synchromed II pump; Other Names: Prior peristaltic Synchromed II pump
NO_INTERVENTION: Retrospective records for peristaltic pump; Prior pain scores and drug doses from the patients who need a new valve gated pump will be recorded and used for comparison after it is changed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduced pain medication through Prometra Implantable Pump System	Total consumption of pain medications both oral and intrathecal is recorded to show changes.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analog Scale for Pain changes	Visual Analog Scale (VAS) for Pain is used assess pain throughout the study which shows No pain at low end to extreme Pain at high end.	12 months
Owestry Disability Index changes	Owestry Disability Index (ODI) are used to assess changes in lifestyle scores throughout the study which shows patient's level of function in daily living	12 months
Global Pain Scale Assessments	Global Pain Scale Assessments will be used to assess changes in scores throughout the study	12 months

Collaborators and Investigators

• Sponsor: Bux, Anjum, MD
• Collaborators: Flowonix Medical
• Investigators: Principal Investigator: Anjum Bux, MD, Owner

Publications and helpful links

General Publications

• Knight KH, Brand FM, Mchaourab AS, Veneziano G. Implantable intrathecal pumps for chronic pain: highlights and updates. Croat Med J. 2007 Feb;48(1):22-34.
• Deer TR, Smith HS, Cousins M, Doleys DM, Levy RM, Rathmell JP, Staats PS, Wallace M, Webster LR. Consensus guidelines for the selection and implantation of patients with noncancer pain for intrathecal drug delivery. Pain Physician. 2010 May-Jun;13(3):E175-213.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 27, 2020
• Primary Completion (ANTICIPATED): April 1, 2023
• Study Completion (ANTICIPATED): November 30, 2023

Study Registration Dates

• First Submitted: March 16, 2020
• First Submitted That Met QC Criteria: March 16, 2020
• First Posted (ACTUAL): March 18, 2020

Study Record Updates

• Last Update Posted (ACTUAL): July 7, 2021
• Last Update Submitted That Met QC Criteria: July 2, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: IDDS; Intrathecal drug therapy; pain pump
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Chronic Pain; Pain, Intractable
• Other Study ID Numbers: T-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No