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Data Collection for Development of a Bladder Sensor During Urodynamics

NCT05305846 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2024-03-26

No results posted yet for this study

Summary

This is an explorative, single-center, feasibility study using a prototype of a future Bladder Sensor to collect data during urodynamics. Obtained data shall be used for the continuous development of the future Bladder Sensor, which is intended for use for individuals suffering from urinary incontinence.

Conditions

Interventions

DEVICE

TENA-PROTO2

During urodynamics, the TENA-PROTO2 will be positioned onto the lower abdomen of patients to collect raw data for the continuous development of the future ultrasound bladder sensor.

Sponsors & Collaborators

  • Essity Hygiene and Health AB

    lead INDUSTRY

Principal Investigators

  • Diederick Duijvesz, PhD. · Canisius Wilhelmina Hospital (CWZ)

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-18
Primary Completion
2024-08-31
Completion
2024-10-31

Countries

  • Netherlands

Study Locations

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Entities

Diseases

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 NCT05305846 on ClinicalTrials.gov