Ambulatory Long Length URodynamics Evaluation

Part of paid clinical trials in Hanover, Maryland.

Sponsor
Bright Uro
Study ID
NCT07425015
Status
Recruiting
Apply to this trial

Conditions

  • Benign Prostatic Hyperplasia
  • Home Monitoring
  • Lower Urinary Tract Dysfunction
  • Urinary Bladder, Overactive
  • Urinary Incontinence (UI)
  • Urodynamics
  • Urology

Eligibility Criteria

Sex
ALL
Age
22 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

A prospective, open-label, single arm interventional trial evaluating the safety and performance of the in-clinic and extended monitoring of the lower urinary tract using the Glean Urodynamics System.

Key Dates

Start date
Feb 17, 2026
Status verified
Apr 2026
Primary completion
Jun 30, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
101 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, uroflowmeter, and software apps.

Primary Outcome Measure

Percentage of participants experiencing a qualifying adverse event attributable to the Glean Urodynamics System [ Time Frame: From enrollment to 14 days after device removal ]

Central Contacts

Locations (7)

FacilityCityStateZIPSite coordinators
Chesapeake Urology AssociatesHanoverMaryland21076
Clinical Research Coordinator
410-760-9400
Kaiser J Robertson III, MD (PRINCIPAL_INVESTIGATOR)
Chesapeake Urology AssociatesOwings MillsMaryland21117
Clinical Research Coordinator
410-581-8140
Laura L Giusto, MD (PRINCIPAL_INVESTIGATOR)
Urology of St. LouisSt LouisMissouri63141
Clinical Research Coordinator
314-567-6071
Travis Bullock, MD (PRINCIPAL_INVESTIGATOR)
MetroHealthClevelandOhio44109
Clinical Research Manager
[email protected]
216-778-8445
Jeffrey Mangel, MD (PRINCIPAL_INVESTIGATOR)
Southern Urogynecology Wellness & AestheticsWest ColumbiaSouth Carolina29169
Clinical Research Coordinator
[email protected]
803-457-7000
Jessica Rueb, MD (PRINCIPAL_INVESTIGATOR)
Andrea Pezzella, MD (SUB_INVESTIGATOR)
Sanford HealthSioux FallsSouth Dakota57105
Research Compliance Specialist
[email protected]
605-328-1383
Kevin Benson, MD (PRINCIPAL_INVESTIGATOR)
Urology Partner of North TexasArlingtonTexas76017
Clinical Research Coordinator
[email protected]
682-205-8396
Geoffrey Nuss, MD (PRINCIPAL_INVESTIGATOR)
Keith Xavier, MD (SUB_INVESTIGATOR)
Tracy Cannon-Smith, MD (SUB_INVESTIGATOR)

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Chesapeake Urology Associates· Hanover, MDChesapeake Urology Associates· Owings Mills, MDUrology of St. Louis· St Louis, MOMetroHealth· Cleveland, OHSouthern Urogynecology Wellness & Aesthetics· West Columbia, SCSanford Health· Sioux Falls, SD

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