Transitioning to a Valve -Gated Intrathecal Drug Delivery System (IDDS)

NCT03876158 | Withdrawn Phase 4 DMC FDA Device

• 1 other identifier: ORA# 19011103
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Flowonix Prometra® II Programmable Pump may require a smaller dose of drug when converting from other commercially available intrathecal drug delivery systems (IDDS).

Conditions

Chronic Pain; Intractable Pain; Back Pain

Outcome Measures

Primary Outcomes (1)

• Reduced pain medication through Prometra Implantable Pump System

  Total consumption of Pain medication both oral and intra thecal would also be recorded to show change in pain medication.

  12 months from Implant

Secondary Outcomes (1)

• Change in pain score: Visual Analog Scale for Pain

  12 months from Implant

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 (refill #1, refill #2, refill #3) and will be compared to retrospectively collected pain (VAS) scores and drug doses from the last refill prior to peristaltic pump explant.

Device: Prometra II Programmable Pump system(Flowonix Medical)

Prior records for peristaltic pump

OTHER

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.

Device: Prometra II Programmable Pump system(Flowonix Medical)

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

Prior records for peristaltic pump; Prometra® Programmable Pump

Eligibility Criteria

• Age: 22 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be male or female between the ages of 22 and 85 years
• Be capable of giving informed consent and completing assessments required by the study
• Have pain intensity of greater than 5 out of 10 as measured by VAS
• Have an active existing peristaltic intrathecal drug delivery system
• Have stable drug dosage for at least 6 weeks prior to valve-gated pump implant
• Be an appropriate candidate for surgery
• Be able to comply with required study visits and assessments including English proficiency

You may not qualify if:

• Have a significant pain disorder not intended to be treated with the test device or comparator
• Be terminally ill and/or have a life expectancy of less than 6 months
• Be a pregnant/lactating woman or a woman of child-bearing potential
• Have a systemic or local infection (contraindicated for pump implantation)
• Have history/evidence of an active disruptive psychiatric disorder or other known condition with potential to impact compliance with study visits and assessments
• Have an underlying condition increasing susceptibility to infection

Sponsors & Collaborators

• Rush University Medical Center: lead
• Flowonix Medical: collaborator

Study Sites (1)

Rush University Medical Center Pain Center

Chicago, Illinois, 60612, United States

Location

Related Publications (4)

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

MeSH Terms

Conditions

Chronic Pain; Pain, Intractable; Back Pain

Condition Hierarchy (Ancestors)

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

Study Officials

• Asokumar Buvanendran, MD

  Rush University Medical Center

  STUDY CHAIR

• Timothy R Lubenow, MD

  Rush University Medical Center

  PRINCIPAL INVESTIGATOR

• Robert McCarthy, D. Pharm

  Rush University Medical Center

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: This open-label, non-randomized, single-blind, multi-center study is designed to evaluate effects of a planned 20% dose reduction when converting to valve-gated from a peristaltic pump. Study participants will be blinded (single blind) to the dose reduction aspect of this trial and must remain blinded to this dose reduction information throughout the trial in an attempt to provide an unbiased assessment of the pain encountered by the patient with their pain pump medications used.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Pain Center

Model Details: Prior Peristaltic Synchromed II intrathecal pump's data prior to crossover to valve-gated Flowonix Prometra® II Programmable Pump is recorded to compare.

Study Record Dates

• First Submitted: March 6, 2019
• First Posted: March 15, 2019
• Study Start: October 1, 2019
• Primary Completion: March 1, 2022
• Study Completion: June 1, 2022
• Last Updated: March 12, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)