Transitioning to a Valve -Gated Intrathecal Drug Delivery System

Pain Clinical Trial

— TRANSIT  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04312685
• Other study ID #: T-001
• Status: Enrolling by invitation
• Phase: N/A
• Start date: July 27, 2020
• Est. completion date: November 30, 2023

Study information

• Verified date: July 2021
• Source: Bux, Anjum, MD
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 120
• Est. completion date: November 30, 2023
• Est. primary completion date: April 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

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 Exclusion Criteria: 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

Related Conditions & MeSH terms

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

Intervention

Device:
• Prometra II Programmable Pump system - Flowonix Medical
This valve gated Prometra II Programmable Pump system will be replacing prior peristaltic Synchromed II pump

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Bux, Anjum, MD	Flowonix Medical

Country where clinical trial is conducted

United States, 

References & Publications (6)

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. — View Citation

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. Review. — View Citation

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. Epub 2015 Dec 14. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Visual Analog Scale for Pain changes	Visual Analog Scale (VAS) for Pain is used assess pain throughout the study which shows No pain at low end to extreme Pain at high end.	12 months
Secondary	Owestry Disability Index changes	Owestry Disability Index (ODI) are used to assess changes in lifestyle scores throughout the study which shows patient's level of function in daily living	12 months
Secondary	Global Pain Scale Assessments	Global Pain Scale Assessments will be used to assess changes in scores throughout the study	12 months