101 Participants NeededMy employer runs this trial

Glean Urodynamics System for Bladder Dysfunction

(ALLURE Trial)

Recruiting at 6 trial locations
BU
SR
Overseen BySuranjan Roychowdhury, PhD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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?

BC

Brittany Carter, DHSc, MPH

Principal Investigator

Bright Uro

Are You a Good Fit for This Trial?

Inclusion Criteria

I am eligible to have urodynamic testing as part of my care.
Patient is able to provide informed consent
I am 22 years old or older.

Exclusion Criteria

Patient has used antibiotics within the past 7 days from the baseline/screening visit
I have been diagnosed with chronic pelvic or bladder pain syndrome.
Patient diagnosed with neurogenic LUTD
See 12 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

In-clinic Monitoring

Subjects will have the Glean Urodynamics System inserted for an in-clinic ambulatory monitoring period

1 day
1 visit (in-person)

Extended Monitoring

Subjects are discharged with the Glean Bladder Sensor in place for continued monitoring outside the clinic, not exceeding 24 hours

1 day

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

14 days
1 phone call

What Are the Treatments Tested in This Trial?

Interventions

  • Glean Urodynamics System

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Glean Urodynamics SystemExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Bright Uro

Lead Sponsor

Trials
2
Recruited
70+