MedTrace Logo

Transitioning to a Valve -Gated Intrathecal Drug Delivery System

NCT04312685 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2021-07-07

No results posted yet for this study

Summary

This study is designed to explore if the valve-gated pump requires less drug to manage subject pain than the prior standard peristaltic pump in the same subject. The newly implanted valve-gated pump will be programmed to deliver a minimum dose reduction of 20% of the same medication that was delivered in the peristaltic pump prior to explant. The drug therapy will be evaluated and pain scores will be evaluated over time (3 refill cycles prospectively for the valve-gated pump and 6 months retrospectively for the peristaltic pump).

Conditions

  • Pain
  • Pain, Chronic
  • Pain, Intractable
  • Pain, Back

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

  • Bux, Anjum, MD

    lead OTHER

Principal Investigators

  • Anjum Bux, MD · Owner

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-07-27
Primary Completion
2023-04-01
Completion
2023-11-30
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 NCT04312685 on ClinicalTrials.gov