Status:
COMPLETED
e۰Sense® Catheter Clinical Investigation
Lead Sponsor:
Laborie Medical Technologies Inc.
Conditions:
Urodynamics
Eligibility:
All Genders
21+ years
Phase:
NA
Brief 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 ca...
Detailed Description
The study will recruit and consent up to 65 subjects from up to 4 different sites (minimum 15 subjects recruited at each site) in the European Union, and the expected duration of each subject's partic...
Eligibility Criteria
Inclusion
- Male and Female subjects (Age: 21 years and over) who are medically indicated for UDS testing.
Exclusion
- Subjects with significant cognitive deficiency that prevent the subject from giving informed consent
- Subjects suffering from an active bladder infection (not including subjects with asymptomatic bacteriuria)
- Pregnant women
- Subjects with recent (less than 2 weeks) pelvic floor surgery
- Subjects who require the use of a suprapubic catheter
Key Trial Info
Start Date :
June 16 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 7 2023
Estimated Enrollment :
61 Patients enrolled
Trial Details
Trial ID
NCT04438499
Start Date
June 16 2020
End Date
September 7 2023
Last Update
December 12 2024
Active Locations (2)
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1
Hôpital Tenon AP-HP (Sorbonne Université)
Paris, France, 75020
2
Rehabilitationszentrum Godeshöhe
Bonn, Germany