Trials / Recruiting
RecruitingNCT05694793
Trial for Reliability of Urodynamics SysTem
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 28 (estimated)
- Sponsor
- Bright Uro · Industry
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Glean Urodynamics System | Wireless, catheter-free urodynamics system |
| DEVICE | Glean Urodynamics System | Wireless and catheter free urodynamics system |
Timeline
- Start date
- 2025-06-03
- Primary completion
- 2026-07-01
- Completion
- 2026-07-01
- First posted
- 2023-01-23
- Last updated
- 2025-09-19
Locations
4 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05694793. Inclusion in this directory is not an endorsement.