MedTrace Logo

e۰Sense® Catheter Clinical Investigation

NCT04438499 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 61

Last updated 2024-12-12

Study results available
· View outcomes & findings →

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.

Conditions

  • Urodynamics

Interventions

DEVICE

eSense 7fr Single Sensor Bladder Catheter

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

Sponsors & Collaborators

  • Laborie Medical Technologies Inc.

    lead INDUSTRY

Principal Investigators

  • Ruth Kirschner-Hermanns, MD · Rehabilitationszentrum Godeshöhe

  • Gérard Amarenco, Prof, M.D. · Hôpital Tenon AP-HP, Sorbonne Université

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-16
Primary Completion
2020-12-17
Completion
2023-09-07

Countries

  • France
  • Germany

Study Locations

More Related Trials

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 NCT04438499 on ClinicalTrials.gov