Trials / Recruiting
RecruitingNCT07425015
Ambulatory Long Length URodynamics Evaluation
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 101 (estimated)
- Sponsor
- Bright Uro · Industry
- Sex
- All
- Age
- 22 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
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.
Conditions
- Urology
- Urinary Bladder, Overactive
- Benign Prostatic Hyperplasia
- Urodynamics
- Home Monitoring
- Urinary Incontinence (UI)
- Lower Urinary Tract Dysfunction
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Glean Urodynamics System | Glean Urodynamics System including a bladder pressure sensor, abdominal pressure sensor, uroflowmeter, and software apps. |
Timeline
- Start date
- 2026-02-17
- Primary completion
- 2027-06-01
- Completion
- 2027-06-01
- First posted
- 2026-02-20
- Last updated
- 2026-04-15
Locations
7 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT07425015. Inclusion in this directory is not an endorsement.