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Clinical Trial Summary

This Registry study will prospectively evaluate the differences in treatment outcomes in terms of pain intensity, pain interference, concomitant medication use, health-related quality of life, opioid adverse effects, and healthcare utilization between targeted drug delivery and conservative medication management only groups.


Clinical Trial Description

This is a prospective, open-label, short term patient registry where up to 169 subjects with cancer associated pain will be enrolled. Subjects with cancer associated pain who are receiving conservative medical management (CMM) only and cancer patients receiving Intrathecal Drug Delivery system (IDDs) along with CMM will be followed for up to 3 months. Subjects will be evaluated monthly up to 3 months from the medical care initiation which is the implant day for the IDDs group and start of the new treatment plan for the CMM group. Subjects that decide to cross-over to the IDDs group in a future date, will still be followed for their progress. Based on routine care, subjects will be seen at day of implant, 1 month post-implant, 2 months post-implant, and 3 months post-implant. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05674240
Study type Observational [Patient Registry]
Source Aurora Health Care
Contact Mansoor M Aman, MD
Phone 9204564030
Email mansoor.aman@aah.org
Status Recruiting
Phase
Start date December 6, 2022
Completion date December 6, 2025

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