Transitioning to a Valve -Gated Intrathecal Drug Delivery System

NCT04312685 | Unknown FDA Device

• 1 other identifier: T-001
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 8

Brief 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

Keywords

IDDS; Intrathecal drug therapy; pain pump

Outcome Measures

Primary Outcomes (1)

• Reduced pain medication through Prometra Implantable Pump System

  Total consumption of pain medications both oral and intrathecal is recorded to show changes.

  12 months

Secondary Outcomes (3)

• Visual Analog Scale for Pain changes

  12 months

• Owestry Disability Index changes

  12 months

• Global Pain Scale Assessments

  12 months

Study Arms (2)

Prometra Programmable Pump

ACTIVE COMPARATOR

Pain scores and drug doses will be prospectively collected for valve-gated Prometra® Programmable Pump system(Flowonix Medical)' at (refills 1-3) and will be compared to 3 months retrospectively collected pain scores (VAS, ODI and Global Pain Scale Assessments) and drug doses prior to peristaltic pump explant.

Device: Prometra II Programmable Pump system - Flowonix Medical

Retrospective records for peristaltic pump

NO INTERVENTION

Prior pain scores and drug doses from the patients who need a new valve gated pump will be recorded and used for comparison after it is changed.

Interventions

Prometra II Programmable Pump system - Flowonix Medical DEVICE

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

Also known as: Prior peristaltic Synchromed II pump

Prometra Programmable Pump

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects meeting all of the following criteria will be eligible for enrollment in the study:
• 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

Sponsors & Collaborators

• Bux, Anjum, MD: lead
• Flowonix Medical: collaborator

Study Sites (8)

Pain and Spine Specialists

Idaho Falls, Idaho, 83404, United States

Location

Crimson Pain Management

Overland Park, Kansas, 66209, United States

Location

Bux Pain Management

Lexington, Kentucky, 40509, United States

Location

Aust Interventional Pain

Slidell, Louisiana, 70458, United States

Location

Michigan Head & Spine Institute

Southfield, Michigan, 48034, United States

Location

National Spine & Pain Center

Turnersville, New Jersey, 08012, United States

Location

The Spine Center at Ridgeway

Rochester, New York, 14626, United States

Location

Consultants in Pain Management

Chattanooga, Tennessee, 37421, United States

Location

Related Publications (6)

• Knight KH, Brand FM, Mchaourab AS, Veneziano G. Implantable intrathecal pumps for chronic pain: highlights and updates. Croat Med J. 2007 Feb;48(1):22-34.

  PMID: 17309136 BACKGROUND

• Deer TR, Smith HS, Cousins M, Doleys DM, Levy RM, Rathmell JP, Staats PS, Wallace M, Webster LR. Consensus guidelines for the selection and implantation of patients with noncancer pain for intrathecal drug delivery. Pain Physician. 2010 May-Jun;13(3):E175-213.

  PMID: 20495597 BACKGROUND

• Hayek SM, Deer TR, Pope JE, Panchal SJ, Patel VB. Intrathecal therapy for cancer and non-cancer pain. Pain Physician. 2011 May-Jun;14(3):219-48.

  PMID: 21587327 BACKGROUND

• Hayek SM, Veizi E, Hanes M. Intrathecal Hydromorphone and Bupivacaine Combination Therapy for Post-Laminectomy Syndrome Optimized with Patient-Activated Bolus Device. Pain Med. 2016 Mar;17(3):561-571. doi: 10.1093/pm/pnv021. Epub 2015 Dec 14.

  PMID: 26814257 BACKGROUND

• Konrad PE, Huffman JM, Stearns LM, Plunkett RJ, Grigsby EJ, Stromberg EK, Roediger MP, Wells MD, Weaver TW. Intrathecal Drug Delivery Systems (IDDS): The Implantable Systems Performance Registry (ISPR). Neuromodulation. 2016 Dec;19(8):848-856. doi: 10.1111/ner.12524. Epub 2016 Oct 12.

  PMID: 27730704 BACKGROUND

• Tangen KM, Leval R, Mehta AI, Linninger AA. Computational and In Vitro Experimental Investigation of Intrathecal Drug Distribution: Parametric Study of the Effect of Injection Volume, Cerebrospinal Fluid Pulsatility, and Drug Uptake. Anesth Analg. 2017 May;124(5):1686-1696. doi: 10.1213/ANE.0000000000002011.

  PMID: 28431428 BACKGROUND

MeSH Terms

Conditions

Pain; Chronic Pain; Pain, Intractable; Back Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Anjum Bux, MD

  Owner

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: subject will be blinded to dosing decreases and increases
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Open-Label, Non-Randomized, Single-Blind, Multi-Center

Study Record Dates

• First Submitted: March 16, 2020
• First Posted: March 18, 2020
• Study Start: July 27, 2020
• Primary Completion: April 1, 2023
• Study Completion: November 30, 2023
• Last Updated: July 7, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (8)