Ignite Creation Date:
2024-05-06 @ 3:55 PM
Last Modification Date:
2024-10-26 @ 1:59 PM
Study NCT ID:
NCT04800523
Status:
WITHDRAWN
Last Update Posted:
2021-10-28
First Post:
2021-03-11
Brief Title:
UroMonitor Trial in Spinal Cord Injury
Sponsor:
University of British Columbia
Organization:
University of British Columbia
Study Overview
Official Title:
The UroMonitor Trial Safety Feasibility and Tolerability of UroMonitor Insertion in Spinal Cord Injury
Status:
WITHDRAWN
Status Verified Date:
2021-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Similar study already completed
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study aims to determine if a non-functioning UroMonitor device can be safely inserted monitored and removed in patients with SCI
Detailed Description:
This prospective observational study will be conducted with 10 patients with chronic thoracolumbar SCI who are already undergoing routine UDS studies as part of their care Following their routine UDS a non-functioning UroMonitor device will be inserted and removed after 3 hours Participants symptoms will be monitored after the UroMonitor is inserted following the 3 hour monitoring period and again after UroMonitor removal A second cystoscopy will be conducted for research purposes after removal to examine the urethra and bladder for any irritation or trauma During insertion and removal the urologist will document the time required for insertion and any difficulties encountered
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None