CompletedNot Applicable

e۰Sense® Catheter Clinical Investigation

France, Germany61 participantsStarted 2020-06-16

Plain-language 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.

Who can participate

Age range21 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Male and Female subjects (Age: 21 years and over) who are medically indicated for UDS testing. Exclusion Criteria: * 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

What they're measuring

Clinician Safety and Effectiveness Rating of eSense Catheters (Per Patient)

Timeframe: approximately 60 minutes

Trial details

NCT IDNCT04438499

SponsorLaborie Medical Technologies Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2020-12-17

Results submitted2021-12-08

View on ClinicalTrials.gov More Urodynamics trials