Trials / Completed
CompletedNCT03761277
Embrace TDD: Post-Market Study to Evaluate Intrathecal Morphine as an Alternative to Systemic Opioids for Chronic Pain
Embrace TDD: Prospective, Multi-Center, Post Market Study to Evaluate Intrathecal (IT) Morphine as an Alternative to Systemic Opioids for the Treatment of Chronic, Intractable, Non-Malignant Primary Back Pain With or Without Leg Pain
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 93 (actual)
- Sponsor
- MedtronicNeuro · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
Subjects will be assessed for pain control and opioid-related side effects following a route of delivery change from systemic opioids to IT morphine therapy.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Medtronic SynchroMed™ II infusion system | Implanted infusion system consisting of a pump and catheter, as well as external components of a clinician programmer, refill and catheter access port kits, and the Personal Therapy Manager (myPTM™). |
| DRUG | Preservative-free morphine sulfate (PFMS) | The pharmacological agent used in the pump for this study is limited to a preservative-free morphine sulfate (PFMS). |
Timeline
- Start date
- 2019-01-16
- Primary completion
- 2021-12-06
- Completion
- 2021-12-06
- First posted
- 2018-12-03
- Last updated
- 2023-02-08
- Results posted
- 2023-02-08
Locations
16 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03761277. Inclusion in this directory is not an endorsement.