NCT04312685

Transitioning to a Valve -Gated Intrathecal Drug Delivery System

Transitioning to a Valve -Gated Intrathecal Drug Delivery System (IDDS): An Open-Label, Non-Randomized, Single-Blind, Multi-Center Study

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Bux, Anjum, MD · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Accepted

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).

Detailed description

This study will employ a single-blind where study participants will not be told about the dose reduction of at least 20% when the valve-gated pump is implanted. A study participant has a significant potential to bias when informed they will get less drug with the new pump than they were receiving in the old pump this could subjectively affect pain scores as well. After valve-gated pump implant and dose reduction, the appropriate pain therapy will be provided to adequately address pain management in the opinion of the study investigator using standard of care processes and VAS scores. Once subjects have been implanted with the valve-gated pump they will be started on a minimum 20% dose reduction (same medications and concentrations prior to explant). If at any time during the subjects' treatment it is determined by the investigator that the subjects' treatment dose needs to be increased, the dose can be increased in increments not to exceed 5% (no change to concentration) based on VAS scores at current and last visits.

Conditions

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

Interventions

Type	Name	Description
DEVICE	Prometra II Programmable Pump system - Flowonix Medical	This valve gated Prometra II Programmable Pump system will be replacing prior peristaltic Synchromed II pump

Timeline

• Start date: 2020-07-27
• Primary completion: 2023-04-01
• Completion: 2023-11-30
• First posted: 2020-03-18
• Last updated: 2021-07-07

Locations

8 sites across 1 country: United States

Regulatory

• FDA-regulated device study