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

NCT03876158 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2020-03-12

No results posted yet for this study

Summary

Flowonix Prometra® II Programmable Pump may require a smaller dose of drug when converting from other commercially available intrathecal drug delivery systems (IDDS).

Conditions

Interventions

DEVICE

Prometra II Programmable Pump system(Flowonix Medical)

This valve gated Prometra II Programmable Pump system will be replacing prior peristaltic Synchromed II pump

Sponsors & Collaborators

  • Flowonix Medical

    collaborator INDUSTRY

  • Rush University Medical Center

    lead OTHER

Principal Investigators

  • Asokumar Buvanendran, MD · Rush University Medical Center

  • Timothy R Lubenow, MD · Rush University Medical Center

  • Robert McCarthy, D. Pharm · Rush University Medical Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
22 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-31
Primary Completion
2022-03-31
Completion
2022-06-30
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 NCT03876158 on ClinicalTrials.gov