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Post-market, Randomized, Controlled, Prospective Study Evaluating Intrathecal Pain Medication (IT) Versus Conventional Medical Management (CMM) in the Non-cancer, Refractory, Chronic Pain Population

NCT04096391 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 73

Last updated 2022-05-18

No results posted yet for this study

Summary

This study is being conducted to compare intrathecal morphine using the commercially available intrathecal drug delivery systems (IDDS), and conventional medical management (CMM) in subjects with non-cancer, refractory chronic pain.

Conditions

  • Chronic Nonmalignant Pain
  • Pain, Intractable
  • Pain, Chronic

Interventions

DEVICE

Flowonix Prometra® II Programmable Infusion System

The Flowonix Prometra® II Programmable Infusion System consists of an implanted infusion pump and catheter, and external components including a clinician programmer, refill and catheter access port kits, the PTC™(a subject operated controller).

DRUG

Pain Medicine

Injections, spinal cord stimulation, peripheral nerve stimulation, pain medication, etc.

Sponsors & Collaborators

  • Flowonix Medical

    collaborator INDUSTRY

  • Celéri Health, Inc.

    collaborator INDUSTRY

  • Advanced Infusion Solutions

    collaborator UNKNOWN

  • Evolve Restorative Center

    lead OTHER

Principal Investigators

  • Jason E Pope, MD · Evolve Restorative Center

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-05
Primary Completion
2022-04-11
Completion
2022-04-11
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04096391 on ClinicalTrials.gov