CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 61 enrolled
Drug / intervention
eSense 7fr Single Sensor Bladder Catheterdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04438499
NCT04438499N/ACompleted

e۰Sense® Clinical Investigation: Assessing the Performance, Safety and Usability of e۰Sense® Electronic Catheters for Performing Urodynamic Studies

Laborie Medical Technologies Inc.·interventional·Posted Jun 18, 2020·Updated Dec 12, 2024

In Brief

A clinical study evaluating eSense 7fr Single Sensor Bladder Catheter for Urodynamics. Completed, enrolled 61 participants across 2 sites in 2 countries.

Detailed Summary

This pre-market study will be conducted on consenting patients undergoing a medically prescribed, invasive, conventional urodynamics (UDS) test using the investigational device (e۰Sense® urodynamic catheters). Data pertaining to the safety, effectiveness and usability of the catheters will be collected.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsUrodynamics
CountriesFrance, Germany
Collaborators--

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedJun 18, 2020
Enrollment StartJun 16, 2020
Primary CompletionDec 17, 2020
Study CompletionSep 7, 2023
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 6.0 years ago

Interventions

eSense 7fr Single Sensor Bladder Catheterdevice

Urinary and abdominal catheters inserted in to the body to measure pressure for urodynamics.