Pain Clinical Trial
— TRANSITOfficial title:
Transitioning to a Valve -Gated Intrathecal Drug Delivery System (IDDS): An Open-Label, Non-Randomized, Single-Blind, Multi-Center Study
Verified date | July 2021 |
Source | Bux, Anjum, MD |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Bux, Anjum, MD | Flowonix Medical |
United States,
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
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 |
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