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

Chronic 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, Cross-Over Study (TRANSIT)

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03876158
• Other study ID #: ORA# 19011103
• Status: Withdrawn
• Phase: Phase 4
• Start date: October 2019
• Est. completion date: June 2022

Study information

• Verified date: March 2020
• Source: Rush University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2022
• Est. primary completion date: March 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Chronic Pain
• Intractable Pain
• 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	Rush University Medical Center Pain Center	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Rush University Medical Center	Flowonix Medical

Country where clinical trial is conducted

United States, 

References & 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. 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

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: 10.111 — 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 Ma — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in pain score: Visual Analog Scale for Pain	Visual Analog Scale for Pain is being used assess the pain throughout the 12 month which shows No pain at one end to Pain as bad as it could be at other end.	12 months from Implant