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

NCT04530955 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 92

Last updated 2020-09-28

No results posted yet for this study

Summary

Comparing the efficacy of Intracthecal Baclofen dose between the Prometra II and Medtronic SynchroMed II for patients with spasticity and with current a current SyncroMed II pump needing replacement.

Conditions

  • Injuries, Spinal Cord
  • CVA (Cerebrovascular Accident)
  • Traumatic Brain Injury
  • MS (Multiple Sclerosis)
  • Muscle Spasticity
  • Cerebral Palsy, Spastic

Interventions

DEVICE

Prometra II Programmable Pump - Flowonix Medical

The valve gated Prometra II Programmable Pump will be replacing the prior peristaltic Synchromed II pump and a 20% dose decrease will be performed at the time of the replacement.

Sponsors & Collaborators

  • Flowonix Medical

    collaborator INDUSTRY

  • Culicchia Neurological Clinic

    lead OTHER

Principal Investigators

  • Andrea Toomer, MD · Culicchia Neurological Clinic Partner

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
22 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-09-24
Primary Completion
2022-12-31
Completion
2023-06-30
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT04530955 on ClinicalTrials.gov