Ambulatory Long Length URodynamics Evaluation
NCT07425015 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 101
Last updated 2026-04-15
Summary
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.
Conditions
- Urology
- Urinary Bladder, Overactive
- Benign Prostatic Hyperplasia
- Urodynamics
- Home Monitoring
- Urinary Incontinence (UI)
- Lower Urinary Tract Dysfunction
Interventions
- DEVICE
-
Glean Urodynamics System
Glean Urodynamics System including a bladder pressure sensor, abdominal pressure sensor, uroflowmeter, and software apps.
Sponsors & Collaborators
-
Bright Uro
lead INDUSTRY
Principal Investigators
-
Brittany Carter, DHSc, MPH · Bright Uro
Study Design
- Allocation
- NA
- Purpose
- OTHER
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 22 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-02-17
- Primary Completion
- 2027-06-30
- Completion
- 2027-06-30
- FDA Device
- Yes
Countries
- United States
Study Locations
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