Ignite Creation Date:
2025-12-24 @ 2:44 PM
Ignite Modification Date:
2026-02-20 @ 10:44 PM
Study NCT ID:
NCT02578459
Status:
WITHDRAWN
Last Update Posted:
2019-02-15
First Post:
2015-10-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Pilot Study to Evaluate the Efficacy of ITDD vs. CMM in the Treatment of Pancreatic Cancer Pain
Sponsor:
Flowonix Medical
Organization:
Study Overview
Official Title:
A Pilot Study to Evaluate the Efficacy of ITDD vs. CMM in the Treatment of Pancreatic Cancer Pain
Status:
WITHDRAWN
Status Verified Date:
2018-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The study was never initiated by sponsor. Patients where never recruited.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
Detailed Description:
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: