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Detectability of the Bladder With an Early Prototype of the Bladder Sensor

NCT04720222 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 91

Last updated 2021-11-24

No results posted yet for this study

Summary

This is an explorative, monocentric, feasibility study to evaluate the detectability of the bladder in healthy subjects by ultrasound monitoring with the early prototype of a future bladder sensor, which is intended for use for an individual suffering from urinary incontinence.

Conditions

Interventions

DEVICE

TENA-PROTO1

Each volunteer will test the TENA-PROTO1 according to a standardized protocol in multiple postural positions to evaluate the detectability of the bladder by help of the investigational device

Sponsors & Collaborators

  • Essity Hygiene and Health AB

    lead INDUSTRY

Principal Investigators

  • Pieter Dik, Prof. · Department of Pediatric Urology, Wilhelmina Children's Hospital UMC Utrecht, P.O. Box 85090, 3508, AB, the Netherlands

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
35 Years
Max Age
74 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-04-29
Primary Completion
2021-10-19
Completion
2021-10-19

Countries

  • Netherlands

Study Locations

More Related Trials

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 NCT04720222 on ClinicalTrials.gov