Embrace TDD: Post-Market Study to Evaluate Intrathecal Morphine as an Alternative to Systemic Opi… (NCT03761277) | Clinical Trial Compass
CompletedPhase 4
Embrace TDD: Post-Market Study to Evaluate Intrathecal Morphine as an Alternative to Systemic Opioids for Chronic Pain
United States93 participantsStarted 2019-01-16
Plain-language summary
This is a prospective, multi-center, post market study to evaluate Intrathecal (IT) preservative-free morphine sulfate (PFMS) using the SynchroMed™ II infusion system as an alternative to systemic opioids for the treatment of chronic, intractable, non-malignant primary back pain with or without leg pain.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Willing and able to provide a signed and dated (Medtronic and Institutional Review Board (IRB) approved) Informed Consent Form (ICF) and Health Insurance Portability and Accountability Act (HIPAA) Authorization Form prior to any study procedures being performed
. A candidate per labeling for the Intrathecal Drug Delivery System (IDDS)
. A diagnosis of chronic, intractable, non-malignant primary back pain with or without leg pain, treatable with the IDDS
. Current daily systemic opioid dose of \>0 and ≤ 120 Morphine Milligram Equivalents (MME)
. A Visual Analogue Scale (VAS) of ≥50 mm for pain intensity at the Baseline Visit and/or a Numerical Opioid Side Effect (NOSE) Assessment Tool ≥40 for intolerable side effects at the Baseline Visit
. Psychological evaluation or investigator assessment of patient psychological suitability for study participation
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Participants With Clinical Success at the 6-Month Visit
. Has an MRI or CT prior to enrollment verifying patent spinal canal and no clinical change in status since last imaging
. At least 18 years old at time of enrollment
Exclusion criteria
. Previously trialed or implanted with an IDDS
. Concomitant stimulation device implanted for the treatment of pain
. Any ongoing health condition that would be expected to interfere with pain and/or quality of life ratings (i.e. active malignancy, other painful conditions not treatable with IT therapy, etc.)
. Psychological or other health conditions, financial and/or legal concerns that would interfere with the subject's ability to fulfill the requirements of the protocol as per the investigator's discretion
. Substance Use Disorder (SUD) within the last 2 years or current Medication Assisted Treatment (MAT) for substance use disorder
. Currently using cannabinoids or illicit drugs
. History of allergy or significant adverse reaction to morphine per investigator discretion
. Currently participating or plans to participate in another investigational study unless written approval is provided by Medtronic Study Team