UrologyNCT07558655
The Glean Registry
An observational study of Urology and Urodynamics, run by Bright Uro at 1 site in United States.
Trial summary
A registry designed to collect real-world data (RWD) on the Glean Urodynamics System via a retrospective medical chart review. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Urology, Urodynamics
- What is being tested?
- Glean Urodynamics System
- Type of treatment
- Medical device
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Apr 2026to May 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Male and female adults age 22 year or older who underwent Glean Urodynamics.
Who may be able to join
- 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
Who cannot join
- Did not have both pressure and flow urodynamic parameters recorded using Glean.
Trial locations and contacts
1 site in 1 country.
United States1 site
Palmetto Adult and Children's Urology
North Charleston, South Carolina, 29406
About this study
Official title: 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.
- Conditions
- Urology, Urodynamics
- Being tested
- Glean Urodynamics System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glean Urodynamics SystemDevice
Glean Urodynamics System including pressure and flow measurements, and software apps.
What is being measured
The primary outcome is the main question the study is designed to answer.
Collection of Demographic and Procedural Information on Patients Who Underwent Glean Urodynamics
Measured: Perioperative/Periprocedural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2026
- Study start16 Apr 2026
- Primary completionMay 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for UrologyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bright Uro
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07558655
- Sponsor's protocol ID
- CIP-0011
- Status last verified
- Apr 2026
- First submitted
- 21 Apr 2026
- Last updated
- 30 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 41810746Kim 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.
PubMed 40314068
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Glean Registry: Real World Data Collection on the Use of the Glean Urodynamics System
- ClinicalTrials.gov ID
- NCT07558655
- Acronym / sponsor ID
- CIP-0011
- Conditions
- Urology, Urodynamics
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Bright UroIndustry (pharma, biotech, devices)
- Study start
- 16 Apr 2026 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 30 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A registry designed to collect real-world data (RWD) on the Glean Urodynamics System via a retrospective medical chart review.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Male and female adults age 22 year or older who underwent Glean Urodynamics.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Did not have both pressure and flow urodynamic parameters recorded using Glean.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Glean Urodynamics SystemGlean Urodynamics System including pressure and flow measurements, and software apps. | Device | – |
Primary outcome
Collection of Demographic and Procedural Information on Patients Who Underwent Glean Urodynamics
Time frame: Perioperative/Periprocedural
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2026.
- Background: PubMed 41810746Hamson 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.
- Background: PubMed 40314068Kim 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.
- Individual participant dataSharing planned: No
Related trials for Urology
Active, not recruitingObservational study
A Prospective, Non-interventional, Observational Study of Presentation, Treatment Patterns and Outcomes in Atypical Hemolytic Uremic Syndrome Patients
Atypical Hemolytic Uremic Syndrome(aHUS)
Not yet recruitingPhase 2
Effects of Meal Macronutrients on Postprandial Lipids
Nephrotic Syndrome, Lipodystrophy
RecruitingPhase 3
Study of Casdatifan and Cabozantinib Versus Placebo and Cabozantinib in Patients With Advanced Clear Cell Renal Cell Carcinoma
Metastatic Clear Cell Renal Cell Carcinoma, Advanced Clear Cell Renal Cell Carcinoma
RecruitingObservational study
Hereditary Leiomyomatosis Renal Cell Cancer - Study of the Genetic Cause and the Predisposition to Renal Cancer
Renal Tumor Histology, Cutaneous Leiomyoma
Active, not recruitingEarly Phase 1
(CLONEVO): Cell cycLe inhbitiON to Target the EVolution of UrOthelial Cancer
Bladder Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urology and Urodynamics, run by Bright Uro at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 30 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Collection of Demographic and Procedural Information on Patients Who Underwent Glean Urodynamics (time frame: Perioperative/Periprocedural). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07558655, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2026.