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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
101
Glean Urodynamics System including a bladder pressure sensor, abdominal pressure sensor, uroflowmeter, and software apps.
Chesapeake Urology Associates
Hanover, Maryland, United States
RECRUITINGChesapeake Urology Associates
Owings Mills, Maryland, United States
RECRUITINGUrology of St. Louis
St Louis, Missouri, United States
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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
MetroHealth
Cleveland, Ohio, United States
RECRUITINGSouthern Urogynecology Wellness & Aesthetics
West Columbia, South Carolina, United States
RECRUITINGSanford Health
Sioux Falls, South Dakota, United States
RECRUITINGUrology Partner of North Texas
Arlington, Texas, United States
RECRUITING