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

Primary Purpose

Pain, Pain, Chronic, Pain, Intractable

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Prometra II Programmable Pump system - Flowonix Medical
Sponsored by
Bux, Anjum, MD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain focused on measuring IDDS, Intrathecal drug therapy, pain pump

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Pain and Spine Specialists
  • Crimson Pain Management
  • Bux Pain Management
  • Aust Interventional Pain
  • Michigan Head & Spine Institute
  • National Spine & Pain Center
  • The Spine Center at Ridgeway
  • Consultants in Pain Management

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Prometra Programmable Pump

Retrospective records for peristaltic pump

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Reduced pain medication through Prometra Implantable Pump System
Total consumption of pain medications both oral and intrathecal is recorded to show changes.

Secondary Outcome Measures

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.
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
Global Pain Scale Assessments
Global Pain Scale Assessments will be used to assess changes in scores throughout the study

Full Information

First Posted
March 16, 2020
Last Updated
July 2, 2021
Sponsor
Bux, Anjum, MD
Collaborators
Flowonix Medical
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1. Study Identification

Unique Protocol Identification Number
NCT04312685
Brief Title
Transitioning to a Valve -Gated Intrathecal Drug Delivery System
Acronym
TRANSIT
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

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Enrolling by invitation
Study Start Date
July 27, 2020 (Actual)
Primary Completion Date
April 1, 2023 (Anticipated)
Study Completion Date
November 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bux, Anjum, MD
Collaborators
Flowonix Medical

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Pain, Chronic, Pain, Intractable, Pain, Back
Keywords
IDDS, Intrathecal drug therapy, pain pump

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Open-Label, Non-Randomized, Single-Blind, Multi-Center
Masking
Participant
Masking Description
subject will be blinded to dosing decreases and increases
Allocation
Non-Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Prometra Programmable Pump
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Retrospective records for peristaltic pump
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Prometra II Programmable Pump system - Flowonix Medical
Other Intervention Name(s)
Prior peristaltic Synchromed II pump
Intervention Description
This valve gated Prometra II Programmable Pump system will be replacing prior peristaltic Synchromed II pump
Primary Outcome Measure Information:
Title
Reduced pain medication through Prometra Implantable Pump System
Description
Total consumption of pain medications both oral and intrathecal is recorded to show changes.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Visual Analog Scale for Pain changes
Description
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.
Time Frame
12 months
Title
Owestry Disability Index changes
Description
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
Time Frame
12 months
Title
Global Pain Scale Assessments
Description
Global Pain Scale Assessments will be used to assess changes in scores throughout the study
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anjum Bux, MD
Organizational Affiliation
Owner
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pain and Spine Specialists
City
Idaho Falls
State/Province
Idaho
ZIP/Postal Code
83404
Country
United States
Facility Name
Crimson Pain Management
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66209
Country
United States
Facility Name
Bux Pain Management
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40509
Country
United States
Facility Name
Aust Interventional Pain
City
Slidell
State/Province
Louisiana
ZIP/Postal Code
70458
Country
United States
Facility Name
Michigan Head & Spine Institute
City
Southfield
State/Province
Michigan
ZIP/Postal Code
48034
Country
United States
Facility Name
National Spine & Pain Center
City
Turnersville
State/Province
New Jersey
ZIP/Postal Code
08012
Country
United States
Facility Name
The Spine Center at Ridgeway
City
Rochester
State/Province
New York
ZIP/Postal Code
14626
Country
United States
Facility Name
Consultants in Pain Management
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37421
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
17309136
Citation
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.
Results Reference
background
PubMed Identifier
20495597
Citation
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.
Results Reference
background
PubMed Identifier
21587327
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.
Results Reference
background
PubMed Identifier
26814257
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.
Results Reference
background
PubMed Identifier
27730704
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.
Results Reference
background
PubMed Identifier
28431428
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.
Results Reference
background

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Transitioning to a Valve -Gated Intrathecal Drug Delivery System

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