Clinical trial NCT03876158: Transitioning to a Valve -Gated Intrathecal Drug Delivery System (IDDS)
Official title: Transitioning to a Valve -Gated Intrathecal Drug Delivery System (IDDS): An Open-Label, Non-Randomized, Single-Blind, Multi-Center, Cross-Over Study (TRANSIT)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Chronic Pain
Intractable Pain
Back Pain
Lead sponsor: Rush University Medical Center
Sponsor class: OTHER
Collaborators: name: Flowonix Medical
First posted: 2019-03-15
Enrollment: 0
Sex: ALL
Minimum age (years): 22
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Prior Peristaltic Synchromed II intrathecal pump's data prior to crossover to valve-gated Flowonix Prometra® II Programmable Pump is recorded to compare.
Primary purpose: TREATMENT

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).

Detailed description: 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.

This study will compare the historical pain medication dose and pain scores using the peristaltic pump at baseline as well as from the last pump refill visit prior to explant to the prospective pain medication dose and pain scores using the valve-gated pump and collected at refill visits 1, 2 and 3 after valve-gated pump implant (but not exceed 12 months).

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Reduced pain medication through Prometra Implantable Pump System
timeFrame: 12 months from Implant
Secondary outcomes:
measure: Change in pain score: Visual Analog Scale for Pain
timeFrame: 12 months from Implant
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Rush University Medical Center Pain Center
state: Illinois
Study officials:
affiliation: Rush University Medical Center
name: Asokumar Buvanendran, MD
role: STUDY_CHAIR
affiliation: Rush University Medical Center
name: Timothy R Lubenow, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Rush University Medical Center
name: Robert McCarthy, D. Pharm
role: STUDY_DIRECTOR
References:
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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. doi: 10.1093/pm/pnv021. Epub 2015 Dec 14.
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.
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.