Ignite Creation Date:
2025-12-25 @ 1:25 AM
Ignite Modification Date:
2025-12-27 @ 5:36 AM
Study NCT ID:
NCT05694793
Status:
RECRUITING
Last Update Posted:
2025-09-19
First Post:
2023-01-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Trial for Reliability of Urodynamics SysTem
Sponsor:
Bright Uro
Organization:
Study Overview
Official Title:
Trial for Reliability of Urodynamics SysTem
Status:
RECRUITING
Status Verified Date:
2025-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TRUST-1
Brief Summary:
The goal of this prospective trial is to assess the safety and reliability of the Glean Urodynamics System (GUS) in adult females with lower urinary tract symptoms. The main question\[s\] it aims to answer are:
• What is GUS's ability to safely and reliably conduct wireless, catheter-free monitoring of vesical pressure compared to the vesical pressures collected with conventional urodynamics?
Participants will undergo a conventional urodynamics exam, a simultaneous urodynamics exam with GUS, ambulatory urodynamics with GUS, and extended home monitoring with GUS.
Researchers will compare GUS data with that from a conventional urodynamics exam.
• What is GUS's ability to safely and reliably conduct wireless, catheter-free monitoring of vesical pressure compared to the vesical pressures collected with conventional urodynamics?
Participants will undergo a conventional urodynamics exam, a simultaneous urodynamics exam with GUS, ambulatory urodynamics with GUS, and extended home monitoring with GUS.
Researchers will compare GUS data with that from a conventional urodynamics exam.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 1R44DK131700 | NIH | None | https://reporter.nih.gov/quic… | View |