NCT07558655

Brief Summary

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

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
12mo left

Started Apr 2026

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress6%
Apr 2026May 2027

Study Start

First participant enrolled

April 16, 2026

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

April 21, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 30, 2026

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2027

Last Updated

April 30, 2026

Status Verified

April 1, 2026

Enrollment Period

1 year

First QC Date

April 21, 2026

Last Update Submit

April 27, 2026

Conditions

UrologyUrodynamics

Outcome Measures

Primary Outcomes (1)

  • Collection of Demographic and Procedural Information on Patients Who Underwent Glean Urodynamics

    Perioperative/Periprocedural

Interventions

Glean Urodynamics SystemDEVICE

Glean Urodynamics System including pressure and flow measurements, and software apps.

Eligibility Criteria

Age22 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Palmetto Adult and Children's Urology

North Charleston, South Carolina, 29406, United States

Location

Related Publications (2)

  • 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.

    PMID: 41810746BACKGROUND

  • Kim J, Xavier K, Cannon-Smith T, Vaughan T, Vemulapalli S, Zhao H, Aalami-Harandi A, Shah N. The Feasibility and Safety of the Glean Urodynamics System: The Modern Urodynamics System Efficacy Study. J Endourol. 2025 Jun;39(6):625-634. doi: 10.1089/end.2025.0270. Epub 2025 May 2.

    PMID: 40314068BACKGROUND

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 21, 2026

First Posted

April 30, 2026

Study Start

April 16, 2026

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

May 1, 2027

Last Updated

April 30, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)