Embrace TDD: Post-Market Study to Evaluate Intrathecal Morphine as an Alternative to Systemic Opioids for Chronic Pain

PHASE4CompletedINTERVENTIONAL
Enrollment

93

Participants

Timeline

Start Date

January 16, 2019

Primary Completion Date

December 6, 2021

Study Completion Date

December 6, 2021

Conditions
Chronic Non-malignant PainChronic PainPain, BackPain, Leg
Interventions
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).

Trial Locations (16)

19027

Moss Rehabilitation-Einstein Healthcare Network, Elkins Park

22908

University of Virginia Pain Management Center, Charlottesville

23507

Eastern Virginia Medical School, Norfolk

32935

Florida Pain Institute, Merritt Island

45154

Premier Pain Treatment Institute, Mount Orab

63136

Christian Hospital Pain Management, St Louis

63701

Regional Brain & Spine, LLC, Cape Girardeau

73013

Clinical Investigations, LLC, Edmond

75701

Precision Spine Care, Tyler

77555

University of Texas Medical Branch, Galveston

89052

Comprehensive and Interventional Pain Management, Henderson

92009

Coastal Pain and Spinal Diagnostics, Carlsbad

94558

Napa Valley Orthopaedic Medical Group, Napa

99201

Northwest Pain Care, Inc., Spokane

99508

Neuroversion, Anchorage

08043

The Pain Management Center, Voorhees Township

Sponsors

Lead Sponsor

All Listed Sponsors
lead

MedtronicNeuro

INDUSTRY

NCT03761277 - Embrace TDD: Post-Market Study to Evaluate Intrathecal Morphine as an Alternative to Systemic Opioids for Chronic Pain | Biotech Hunter | Biotech Hunter