- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07558655
The Glean Registry
April 27, 2026 updated by: Bright Uro
The Glean Registry: Real World Data Collection on the Use of the Glean Urodynamics System
A registry designed to collect real-world data (RWD) on the Glean Urodynamics System via a retrospective medical chart review.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Estimated)
500
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
South Carolina
-
North Charleston, South Carolina, United States, 29406
- Palmetto Adult and Children's Urology
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Male and female adults age 22 year or older who underwent Glean Urodynamics.
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Collection of Demographic and Procedural Information on Patients Who Underwent Glean Urodynamics
Time Frame: Perioperative/Periprocedural
|
Perioperative/Periprocedural
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 16, 2026
Primary Completion (Estimated)
May 1, 2027
Study Completion (Estimated)
May 1, 2027
Study Registration Dates
First Submitted
April 21, 2026
First Submitted That Met QC Criteria
April 27, 2026
First Posted (Actual)
April 30, 2026
Study Record Updates
Last Update Posted (Actual)
April 30, 2026
Last Update Submitted That Met QC Criteria
April 27, 2026
Last Verified
April 1, 2026
More Information
Terms related to this study
Other Study ID Numbers
- CIP-0011
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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