Establishing Normative Urodynamics Parameters for the Glean Urodynamics System in Healthy Adults

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Bright Uro
Study ID
NCT07485205
Status
Recruiting
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Conditions

  • Lower Urinary Tract Symptoms (LUTS)

Eligibility Criteria

Sex
ALL
Age
18 Years - 45 Years
Healthy Volunteers
Accepted

Interventions

  • Glean Urodynamics System — DEVICE
    Glean Urodynamics System including a bladder pressure sensor, abdominal pressure sensor, in-clinic uroflowmeter, and software apps.

Study Details

A prospective, open-label, single arm interventional trial to establish normative reference ranges for urodynamics parameters in healthy adult participants using using the Glean Urodynamics System.

Key Dates

Start date
Mar 31, 2026
Status verified
Apr 2026
Primary completion
Mar 31, 2027
Completion
Mar 31, 2027

Study Design

Enrollment
72 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

Arms

  • Experimental: Glean Urodynamics System
    Glean Urodynamics System including a bladder pressure sensor, abdominal pressure sensor, in-clinic uroflowmeter, and software apps.

Primary Outcome Measure

Range of vesical pressure (Pves) [ Time Frame: Periprocedurally ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Arizona Research CenterPhoenixArizona85053
Cameron Meek, MD (PRINCIPAL_INVESTIGATOR)
Daniel Jaffee, MD (SUB_INVESTIGATOR)
Del Sol Research ManagementTucsonArizona85715
Wendy Hotz, R.Ph.
[email protected]
Susan Kalota, MD (PRINCIPAL_INVESTIGATOR)
Boulder Medical CenterBoulderColorado80304
Director of Clinical Operations, Altitude Clinical Research
[email protected]
720-475-5728
Stephen B Siegel, MD (PRINCIPAL_INVESTIGATOR)

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Arizona Research Center· Phoenix, AZDel Sol Research Management· Tucson, AZBoulder Medical Center· Boulder, CO

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