Loading clinical trials...
Loading clinical trials...
The purpose of this study is to compare efficacy of pain treatment with ITDD to efficacy of pain treatment with CMM in patients with pancreatic cancer pain.
This study is a non-randomized, open-label, single-center study that will compare efficacy of pain treatment with ITDD to efficacy of pain treatment with CMM in patients suffering from pancreatic cancer pain. There will be two treatment groups: Study group (ITDD): These subjects will have a Prometra System implanted and managed with the appropriate drug regimen to treat their pain. Systemic analgesics will not be prescribed for this group. Control group (CMM): These subjects will be treated with CMM to treat their pain. A maximum of 30 subjects (maximum of 15 in each treatment group) may be enrolled in this study at one study center.
Age
22 - No limit years
Sex
ALL
Healthy Volunteers
No
Menorah Medical Center
Overland Park, Kansas, United States
Start Date
April 1, 2016
Primary Completion Date
December 1, 2016
Completion Date
September 1, 2018
Last Updated
February 15, 2019
Intrathecal Drug Delivery System
DEVICE
Conventional Medical Management
OTHER
Lead Sponsor
Flowonix Medical
NCT07327463
NCT07432711
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and Conditions