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

Primary Purpose

Chronic Pain, Intractable Pain, Back Pain

Status
Withdrawn
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Prometra II Programmable Pump system(Flowonix Medical)
Sponsored by
Rush University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Pain

Eligibility Criteria

22 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Be male or female between the ages of 22 and 85 years
  2. Be capable of giving informed consent and completing assessments required by the study
  3. Have pain intensity of greater than 5 out of 10 as measured by VAS
  4. Have an active existing peristaltic intrathecal drug delivery system
  5. Have stable drug dosage for at least 6 weeks prior to valve-gated pump implant
  6. Be an appropriate candidate for surgery
  7. Be able to comply with required study visits and assessments including English proficiency

Exclusion Criteria:

  1. Have a significant pain disorder not intended to be treated with the test device or comparator
  2. Be terminally ill and/or have a life expectancy of less than 6 months
  3. Be a pregnant/lactating woman or a woman of child-bearing potential
  4. Have a systemic or local infection (contraindicated for pump implantation)
  5. Have history/evidence of an active disruptive psychiatric disorder or other known condition with potential to impact compliance with study visits and assessments
  6. Have an underlying condition increasing susceptibility to infection

Sites / Locations

  • Rush University Medical Center Pain Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Other

Arm Label

Prometra® Programmable Pump

Prior 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 (refill #1, refill #2, refill #3) and will be compared to retrospectively collected pain (VAS) scores and drug doses from the last refill 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 medication both oral and intra thecal would also be recorded to show change in pain medication.

Secondary Outcome Measures

Change in pain score: Visual Analog Scale for Pain
Visual Analog Scale for Pain is being used assess the pain throughout the 12 month which shows No pain at one end to Pain as bad as it could be at other end.

Full Information

First Posted
March 6, 2019
Last Updated
March 10, 2020
Sponsor
Rush University Medical Center
Collaborators
Flowonix Medical
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1. Study Identification

Unique Protocol Identification Number
NCT03876158
Brief Title
Transitioning to a Valve -Gated Intrathecal Drug Delivery System (IDDS)
Acronym
TRANSIT
Official Title
Transitioning to a Valve -Gated Intrathecal Drug Delivery System (IDDS): An Open-Label, Non-Randomized, Single-Blind, Multi-Center, Cross-Over Study (TRANSIT)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Withdrawn
Why Stopped
The study will not be conducted by Dr Lubenow
Study Start Date
October 2019 (Anticipated)
Primary Completion Date
March 2022 (Anticipated)
Study Completion Date
June 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rush University Medical Center
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
Yes

5. Study Description

Brief Summary
Flowonix Prometra® II Programmable Pump may require a smaller dose of drug when converting from other commercially available intrathecal drug delivery systems (IDDS).
Detailed Description
This open-label, non-randomized, single-blind, multi-center study is designed to evaluate effects of a planned 20% dose reduction when converting to valve-gated from a peristaltic pump. Study participants will be blinded (single blind) to the dose reduction aspect of this trial and must remain blinded to this dose reduction information throughout the trial in an attempt to provide an unbiased assessment of the pain encountered by the patient with their pain pump medications used. This study will compare the historical pain medication dose and pain scores using the peristaltic pump at baseline as well as from the last pump refill visit prior to explant to the prospective pain medication dose and pain scores using the valve-gated pump and collected at refill visits 1, 2 and 3 after valve-gated pump implant (but not exceed 12 months).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain, Intractable Pain, Back Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Model Description
Prior Peristaltic Synchromed II intrathecal pump's data prior to crossover to valve-gated Flowonix Prometra® II Programmable Pump is recorded to compare.
Masking
Participant
Masking Description
This open-label, non-randomized, single-blind, multi-center study is designed to evaluate effects of a planned 20% dose reduction when converting to valve-gated from a peristaltic pump. Study participants will be blinded (single blind) to the dose reduction aspect of this trial and must remain blinded to this dose reduction information throughout the trial in an attempt to provide an unbiased assessment of the pain encountered by the patient with their pain pump medications used.
Allocation
Non-Randomized
Enrollment
0 (Actual)

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 (refill #1, refill #2, refill #3) and will be compared to retrospectively collected pain (VAS) scores and drug doses from the last refill prior to peristaltic pump explant.
Arm Title
Prior records for peristaltic pump
Arm Type
Other
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 medication both oral and intra thecal would also be recorded to show change in pain medication.
Time Frame
12 months from Implant
Secondary Outcome Measure Information:
Title
Change in pain score: Visual Analog Scale for Pain
Description
Visual Analog Scale for Pain is being used assess the pain throughout the 12 month which shows No pain at one end to Pain as bad as it could be at other end.
Time Frame
12 months from Implant

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Be male or female between the ages of 22 and 85 years Be capable of giving informed consent and completing assessments required by the study Have pain intensity of greater than 5 out of 10 as measured by VAS Have an active existing peristaltic intrathecal drug delivery system Have stable drug dosage for at least 6 weeks prior to valve-gated pump implant Be an appropriate candidate for surgery Be able to comply with required study visits and assessments including English proficiency Exclusion Criteria: Have a significant pain disorder not intended to be treated with the test device or comparator Be terminally ill and/or have a life expectancy of less than 6 months Be a pregnant/lactating woman or a woman of child-bearing potential Have a systemic or local infection (contraindicated for pump implantation) Have history/evidence of an active disruptive psychiatric disorder or other known condition with potential to impact compliance with study visits and assessments Have an underlying condition increasing susceptibility to infection
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Asokumar Buvanendran, MD
Organizational Affiliation
Rush University Medical Center
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Timothy R Lubenow, MD
Organizational Affiliation
Rush University Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Robert McCarthy, D. Pharm
Organizational Affiliation
Rush University Medical Center
Official's Role
Study Director
Facility Information:
Facility Name
Rush University Medical Center Pain Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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
result
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
result
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
result
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
result

Learn more about this trial

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

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