Glean Urodynamics System for Bladder Dysfunction
(ALLURE Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Who Is on the Research Team?
Brittany Carter, DHSc, MPH
Principal Investigator
Bright Uro
Are You a Good Fit for This Trial?
Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
In-clinic Monitoring
Subjects will have the Glean Urodynamics System inserted for an in-clinic ambulatory monitoring period
Extended Monitoring
Subjects are discharged with the Glean Bladder Sensor in place for continued monitoring outside the clinic, not exceeding 24 hours
Follow-up
Participants are monitored for safety and effectiveness after treatment, including a urine sample 7 days after sensor removal and a follow-up phone call 14 days post-removal
What Are the Treatments Tested in This Trial?
Interventions
- Glean Urodynamics System
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Glean Urodynamics System including a bladder pressure sensor, abdominal pressure sensor, uroflowmeter, and software apps.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Bright Uro
Lead Sponsor
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