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Establishing Normative Urodynamics Parameters for the Glean Urodynamics System in Healthy Adults

NCT07485205 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2026-04-22

No results posted yet for this study

Summary

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.

Conditions

  • Lower Urinary Tract Symptoms (LUTS)

Interventions

DEVICE

Glean Urodynamics System

Glean Urodynamics System including a bladder pressure sensor, abdominal pressure sensor, in-clinic uroflowmeter, and software apps.

Sponsors & Collaborators

  • Bright Uro

    lead INDUSTRY

Principal Investigators

  • Brittany Carter · Bright Uro

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-03-31
Primary Completion
2027-03-31
Completion
2027-03-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07485205 on ClinicalTrials.gov