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Prometra Post-Approval Study

NCT01854229 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2023-10-18

No results posted yet for this study

Summary

The Prometra Pump is approved by the FDA for use in the United States. The purpose of this study is to collect long-term safety data on the Prometra Pump.

Conditions

Interventions

DEVICE

Prometra Programmable Intrathecal Infusion Pump

There are two enrollment groups (arms). One is for new patients who are going to have a Prometra Pump implanted. The other arm is for patients who were part of the IDE study prior to FDA approval of the pump, and are willing to continue to be followed as part of a study.

Sponsors & Collaborators

  • Flowonix Medical

    lead INDUSTRY

Principal Investigators

  • Cory Brantley · Flowonix Medical

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-06-20
Primary Completion
2023-03-15
Completion
2023-03-15

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 NCT01854229 on ClinicalTrials.gov