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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05959655
Other study ID # CIP-0005
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date August 21, 2023
Est. completion date July 2025

Study information

Verified date April 2024
Source Bright Uro
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The goal of this prospective observational trial is to evaluate the feasibility, efficacy, and safety of the Glean Urodynamics System (GUS) for use in the clinic to collect vesical pressure data in adult males and females with lower urinary tract symptoms. The main question[s] it aims to answer are: • What is the feasibility, efficacy, and safety of GUS for use in clinical to collect vesical pressure data in adult males and females with lower urinary tract symptoms? Participants will undergo a planned conventional urodynamics exam after which the Glean Sensor will be inserted and ambulatory urodynamics will be performed with the sensor indwelling in the bladder after which the sensor will be removed.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 50
Est. completion date July 2025
Est. primary completion date July 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Male or female patient must be = 18 years of age - Patient must have a diagnosis of LUTD - Patient must be scheduled for or recommended for cUDS - Patient is able to tolerate 18Fr catheterization - Patient or patient's legally authorized representative is able to provide informed consent Exclusion Criteria: - Pregnant (as confirmed by urine pregnancy test) or breastfeeding, pregnant within the past 6 months or intend to become pregnant during the study period. - Patient has a symptomatic UTI based on CDC guidance (see below) - Subjects who, at the principal investigator's determination, would not be appropriate for this study.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Glean Urodynamics System
Wireless, catheter-free urodynamics system

Locations

Country Name City State
United States Urology Partners of North Texas Arlington Texas
United States Stony Brook Medicine East Setauket New York
United States Tri Valley Urology Murrieta California
United States Hoag Memorial Hospital Presbyterian Newport Beach California
United States Palmetto Adult and Children's Urology North Charleston South Carolina

Sponsors (1)

Lead Sponsor Collaborator
Bright Uro

Country where clinical trial is conducted

United States, 

References & Publications (1)

Frainey BT, Majerus SJA, Derisavifard S, Lewis KC, Williams AR, Balog BM, Butler RS, Goldman HB, Damaser MS. First in Human Subjects Testing of the UroMonitor: A Catheter-free Wireless Ambulatory Bladder Pressure Monitor. J Urol. 2023 Jul;210(1):186-195. doi: 10.1097/JU.0000000000003451. Epub 2023 Jun 9. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Insertion/Removal Success Percent of insertion or removal attempts of the Glean sensor deemed successful during the procedure/surgery
Primary Device-related SAE Device-related serious adverse events up to 2 weeks
Secondary Patient perception Likert scale of comfort during Glean urodynamics; scale 1-5, higher scores are better during the procedure/surgery
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