Transitioning to a Valve -Gated Intrathecal Drug Delivery System

Status unconfirmed · Not applicable

Conditions studied: Pain, Pain, Chronic, Pain, Intractable, Pain, Back

In brief

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).

Key facts

Study ID

NCT04312685

Run by

Bux, Anjum, MD

People needed

120

Starts

2020-07-27

Expected to finish

2023-11-30

Last updated by the study team

2021-07-07

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Subjects meeting all of the following criteria will be eligible for enrollment in the study:
• 21 years of age or older
• Provide written informed consent for study participation
• Active existing peristaltic intrathecal drug delivery system (IDDS)
• Stable IDDS dosage and concentration for at least 6 weeks prior to valve-gated pump implant
• Minimum of 3 months of information from the following:
• VAS, ODI, Global Pain Scale
• Pump refill printouts (dosage and concentration)
• Other Interventions for pain (injections, nerve blocks, etc.)
• Estimated Replacement Indicator (ERI) printout required showing < 12 months of battery life
• Catheter Access Procedure (CAP) study performed to document patency of catheter, if not replacing
• Diagnosis of nonmalignant, chronic intractable pain as documented in medical history
• Appropriate candidate for surgery
• Able to comply with study requirements including visits and assessments, in the opinion of the investigator

You may not qualify if…

• Subjects meeting any of the following criteria will be excluded from participating in the study:
• Any contraindications listed in the Prometra labeling
• Significant pain disorder not intended to be treated with the test device or comparator
• Terminally ill, malignant cancer diagnosis and/or has a life expectancy of less than 12 months in the opinion of the investigator
• Pregnant/lactating woman or is of child-bearing potential and not utilizing effective birth control.
• Systemic or local infection (contraindicated for pump implantation)
• History/evidence of an active disruptive psychiatric disorder or other known condition with potential to impact compliance with study visits and assessments, in the investigator's opinion

Where it is running

• Pain and Spine Specialists — Idaho Falls, Idaho, United States
• Crimson Pain Management — Overland Park, Kansas, United States
• Bux Pain Management — Lexington, Kentucky, United States
• Aust Interventional Pain — Slidell, Louisiana, United States
• Michigan Head & Spine Institute — Southfield, Michigan, United States
• National Spine & Pain Center — Turnersville, New Jersey, United States
• The Spine Center at Ridgeway — Rochester, New York, United States
• Consultants in Pain Management — Chattanooga, Tennessee, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.