The Glean Registry | NCT07558655

Studies
The Glean Registry

NCT07558655

Sponsor

Bright Uro

Status

Active, not recruiting

Last Update Posted

Apr 30, 2026Actual

Enrollment

500Estimated

Phase

Not provided

Conditions

Urology
Urodynamics

Interventions

Glean Urodynamics System

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2026

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 16, 2026Actual

Primary Completion Date

May 2027Estimated

Completion Date

May 2027Estimated

First Submitted Date

Apr 21, 2026

First Submission Date that Met QC Criteria

Apr 27, 2026

First Posted Date

Apr 30, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 27, 2026

Last Update Posted Date

Apr 30, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

A registry designed to collect real-world data (RWD) on the Glean Urodynamics System via a retrospective medical chart review.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

500Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Glean Urodynamics System	Device	Glean Urodynamics System including pressure and flow measurements, and software apps.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Collection of Demographic and Procedural Information on Patients Who Underwent Glean Urodynamics		Perioperative/Periprocedural

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male or female adult age 22 years or older
Underwent UDS testing using the Glean Urodynamics System
Glean UDS has been interpreted by the clinician

Exclusion Criteria:

- Did not have both pressure and flow urodynamic parameters recorded using Glean.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

22 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Male and female adults age 22 year or older who underwent Glean Urodynamics.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Palmetto Adult and Children's Urology		North Charleston	South Carolina	29406	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
41810746	Background	Hamson M, Maahs T, Poulsen A, Nowroozi B, Shamkhalichenar H, Carter BU, Takayoshi T, Flores D, Wibowo H. Comparative Pressure Measurement Performance of the Glean Urodynamics System-a Novel Wireless and Catheter-Free Urodynamics Device. J Endourol. 2026 Mar 11:8927790261430997. doi: 10.1177/08927790261430997. Online ahead of print.
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