An interventional study of Glean Urodynamics System in Urology, Urinary Bladder, Overactive and Benign Prostatic Hyperplasia, sponsored by Bright Uro. Recruiting at 7 sites in United States. Open to participants aged 22 Years and older. Per ClinicalTrials.gov, last updated 2026-04-15.
Sponsored by Bright Uro · Not applicable, Interventional, and Other
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.
Subjects will have the Glean Urodynamics System inserted for an in-clinic ambulatory monitoring period. Afterward, they will be discharged with the Glean Bladder Sensor in place for continued monitoring outside the clinic, not exceeding 24 hours. The sensor will be removed within 24 hours of insertion. Subjects will provide a urine sample 7 days after sensor removal and will receive a follow-up phone call 14 days post-removal.
Exclusion Criteria:
Glean Urodynamics System including a bladder pressure sensor, abdominal pressure sensor, uroflowmeter, and software apps.
Device: Glean Urodynamics System
Glean Urodynamics System including a bladder pressure sensor, abdominal pressure sensor, uroflowmeter, and software apps.
Percentage of participants experiencing a qualifying adverse event attributable to the Glean Urodynamics System
Percentage of participants experiencing a qualifying adverse event attributable to the Glean Urodynamics System
Time frame: From enrollment to 14 days after device removal
Plan to share: No
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Bright Uro