Transitioning to a Valve -Gated Intrathecal Drug Delivery System

NCT ID: NCT04312685

Last Updated: 2021-07-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-27
• Study Completion Date: 2023-11-30

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).

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Prometra Programmable Pump

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.

Group Type: ACTIVE_COMPARATOR

Prometra II Programmable Pump system - Flowonix Medical

Intervention Type: DEVICE

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

Retrospective records for peristaltic pump

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Prometra II Programmable Pump system - Flowonix Medical

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

Intervention Type: DEVICE

Other Intervention Names

Prior peristaltic Synchromed II pump

Eligibility Criteria

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

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Flowonix Medical

INDUSTRY

Sponsor Role: collaborator

Bux, Anjum, MD

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anjum Bux, MD

Role: PRINCIPAL_INVESTIGATOR

Owner

Locations

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

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 17309136 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 20495597 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21587327 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26814257 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 27730704 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28431428 (View on PubMed)

Other Identifiers

T-001

Identifier Type: -

Identifier Source: org_study_id