72 Participants NeededMy employer runs this trial

Glean Urodynamics System for Urinary Function

Recruiting at 2 trial locations
BC
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 to establish normative reference ranges for urodynamics parameters in healthy adult participants using using the Glean Urodynamics System.

Who Is on the Research Team?

BC

Brittany Carter

Principal Investigator

Bright Uro

Are You a Good Fit for This Trial?

Inclusion Criteria

2. Patient is able to read, write, and communicate in English.
4. Patient owns, can independently operate, and is willing to use a smart device for study data collection purposes
3. Patient is able to provide informed consent.
See 1 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)

Out-of-clinic Monitoring

Subjects will be 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

1 week
1 follow-up 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+