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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Glean Urodynamics System | Experimental | Glean Urodynamics System including a bladder pressure sensor, abdominal pressure sensor, uroflowmeter, and software apps. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Glean Urodynamics System | Device | Glean Urodynamics System including a bladder pressure sensor, abdominal pressure sensor, uroflowmeter, and software apps. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | From enrollment to 14 days after device removal |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Brittany U Carter, DHSc, MPH | Contact | 949-202-5689 | brittany@brighturo.com | |
| Suranjan Roychowdhury, PhD | Contact | 949-202-5685 | suranjan@brighturo.com |
| Name | Affiliation | Role |
|---|---|---|
| Brittany Carter, DHSc, MPH | Bright Uro | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chesapeake Urology Associates | Recruiting | Hanover | Maryland | 21076 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40314068 | Background | Kim J, Xavier K, Cannon-Smith T, Vaughan T, Vemulapalli S, Zhao H, Aalami-Harandi A, Shah N. The Feasibility and Safety of the Glean Urodynamics System: The Modern Urodynamics System Efficacy Study. J Endourol. 2025 Jun;39(6):625-634. doi: 10.1089/end.2025.0270. Epub 2025 May 2. |
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| Chesapeake Urology Associates | Recruiting | Owings Mills | Maryland | 21117 | United States |
|
| Urology of St. Louis | Recruiting | St Louis | Missouri | 63141 | United States |
|
| MetroHealth | Recruiting | Cleveland | Ohio | 44109 | United States |
|
| Southern Urogynecology Wellness & Aesthetics | Recruiting | West Columbia | South Carolina | 29169 | United States |
|
| Sanford Health | Recruiting | Sioux Falls | South Dakota | 57105 | United States |
|
| Urology Partner of North Texas | Recruiting | Arlington | Texas | 76017 | United States |
|
| ID | Term |
|---|---|
| D053201 | Urinary Bladder, Overactive |
| D011470 | Prostatic Hyperplasia |
| D014549 | Urinary Incontinence |
| ID | Term |
|---|---|
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011469 | Prostatic Diseases |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D014555 | Urination Disorders |
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