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

Sponsor
Rush University Medical Center (Other)
Overall Status
Withdrawn
CT.gov ID
NCT03876158
Collaborator
Flowonix Medical (Industry)
0
Enrollment
1
Location
2
Arms
32
Anticipated Duration (Months)
0
Patients Per Site Per Month

Study Details

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).

Condition or Disease Intervention/Treatment Phase
  • Device: Prometra II Programmable Pump system(Flowonix Medical)
 Phase 4

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).

Study Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
Non-Randomized
Intervention Model:
Crossover Assignment
Intervention 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.Prior Peristaltic Synchromed II intrathecal pump's data prior to crossover to valve-gated Flowonix Prometra® II Programmable Pump is recorded to compare.
Masking:
Single (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.
Primary Purpose:
Treatment
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)
Anticipated Study Start Date :
Oct 1, 2019
Anticipated Primary Completion Date :
Mar 1, 2022
Anticipated Study Completion Date :
Jun 1, 2022

Arms and Interventions

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 (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.

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

    		•
    Other: Prior 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.

    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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Reduced pain medication through Prometra Implantable Pump System [12 months from Implant]

      Total consumption of Pain medication both oral and intra thecal would also be recorded to show change in pain medication.

    Secondary Outcome Measures

    1. Change in pain score: Visual Analog Scale for Pain [12 months from Implant]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    22 Years to 85 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Rush University Medical Center Pain Center Chicago Illinois United States 60612

    Sponsors and Collaborators

    • Rush University Medical Center
    • Flowonix Medical

    Investigators

    • Study Chair: Asokumar Buvanendran, MD, Rush University Medical Center
    • Principal Investigator: Timothy R Lubenow, MD, Rush University Medical Center
    • Study Director: Robert McCarthy, D. Pharm, Rush University Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Timothy Lubenow, Director, Pain Center, Rush University Medical Center
    ClinicalTrials.gov Identifier:
    NCT03876158
    Other Study ID Numbers:
    • ORA# 19011103
    First Posted:
    Mar 15, 2019
    Last Update Posted:
    Mar 12, 2020
    Last Verified:
    Mar 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Additional relevant MeSH terms:
    Chronic Pain
    Pain, Intractable

    Study Results

    No Results Posted as of Mar 12, 2020