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

March 10, 2020 updated by: Timothy Lubenow, Rush University Medical Center

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

Flowonix Prometra® II Programmable Pump may require a smaller dose of drug when converting from other commercially available intrathecal drug delivery systems (IDDS).

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush University Medical Center Pain Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

22 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

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 (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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reduced pain medication through Prometra Implantable Pump System
Time Frame: 12 months from Implant
Total consumption of Pain medication both oral and intra thecal would also be recorded to show change in pain medication.
12 months from Implant

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in pain score: Visual Analog Scale for Pain
Time Frame: 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.
12 months from Implant

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rush University Medical Center

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

October 1, 2019

Primary Completion (Anticipated)

March 1, 2022

Study Completion (Anticipated)

June 1, 2022

Study Registration Dates

First Submitted

March 6, 2019

First Submitted That Met QC Criteria

March 14, 2019

First Posted (Actual)

March 15, 2019

Study Record Updates

Last Update Posted (Actual)

March 12, 2020

Last Update Submitted That Met QC Criteria

March 10, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ORA# 19011103

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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