Trial for Reliability of Urodynamics SysTem

Part of paid clinical trials in Murrieta, California.

Sponsor
Bright Uro
Study ID
NCT05694793
Status
Recruiting
Apply to this trial

Conditions

  • Urodynamics
  • Urologic Diseases

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Glean Urodynamics System — DEVICE
    Wireless, catheter-free urodynamics system
  • Glean Urodynamics System — DEVICE
    Wireless and catheter free urodynamics system

Study Details

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.

Key Dates

Start date
Jun 3, 2025
Status verified
Apr 2026
Primary completion
Jul 31, 2026
Completion
Jul 31, 2026

Study Design

Enrollment
28 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY

Arms

  • Experimental: Glean Urodynamics System

Primary Outcome Measure

Safety [ Time Frame: From date of enrollment to study exit (up to 43 days) ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
Tri Valley Urology Medical GroupMurrietaCalifornia92562
Anita Deeds
[email protected]
951-698-1901
Monish Crisell, MD (PRINCIPAL_INVESTIGATOR)
University of California San DiegoSan DiegoCalifornia92121-
Unio Health PartnersTorrenceCalifornia90503-
Cleveland ClinicClevelandOhio44195-

Find similar trials in Murrieta, CA

By research site
Tri Valley Urology Medical Group· Murrieta, CAUniversity of California San Diego· San Diego, CAUnio Health Partners· Torrence, CACleveland Clinic· Cleveland, OH

Related Studies