e۰Sense® Catheter Clinical Investigation

NCT04438499 | Completed Results

• 1 other identifier: ESNS-PH01
• Study Type: interventional
• Target: 61
• Locations: 2 countries
• Sites: 2

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 catheters). Data pertaining to the safety, effectiveness and usability of the catheters will be collected.

Conditions

Urodynamics

Keywords

urodynamics; urinary catheter

Outcome Measures

Primary Outcomes (1)

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

  The primary objective of the study is to gather clinical data to confirm that the updated e۰Sense® catheters are safe and effective for urodynamic use in subjects medically indicated for urodynamics testing. The primary outcome will be measured by recording the clinician safety and effectiveness rating for each subject on their CRF. The clinicians will indicate whether each of the e۰Sense® bladder and abdominal catheters are safe \& effective for urodynamic use. Given the intended use of the device, and the fact that there is no single or combined objective measures generated from the UDS test that can establish the safety and effectiveness, it is justified to obtain clinicians' feedback via a binary response whether the device is safe and effective for urodynamic use.

  approximately 60 minutes

Secondary Outcomes (1)

• To Report the Percentage of Participants Free From Severe Complication for the Updated e۰Sense Catheters

  approximately 60 minutes

Other Outcomes (4)

• Assess User Impression Based on Subjective Measures

  approximately 60 minutes

• Asses Subjective Discomfort Levels in the Study Population

  approximately 60 minutes

• Assess Resting Pressures in the Subject Before Urodynamics

  approximately 60 minutes

Study Arms (1)

Subjects Indicated for a UDS study

EXPERIMENTAL

The investigational device, i.e. the eSense catheter will be used in all the subjects to assess primary and exploratory objectives. It is a single arm study with no comparative, placebo, sham or control arm.

Device: eSense 7fr Single Sensor Bladder Catheter

Interventions

eSense 7fr Single Sensor Bladder Catheter DEVICE

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

Also known as: eSense 7Fr Abdominal Catheters, eSense 7Fr Dual Sensor Urethral Catheters

Subjects Indicated for a UDS study

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and Female subjects (Age: 21 years and over) who are medically indicated for UDS testing.

You may not qualify if:

• 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

Sponsors & Collaborators

• Laborie Medical Technologies Inc.: lead

Study Sites (2)

Hôpital Tenon AP-HP (Sorbonne Université)

Paris, 75020, France

Location

Rehabilitationszentrum Godeshöhe

Bonn, Germany

Location

Related Publications (1)

• Fleiss, J.L., Levin, B., & Cho Paik, M. (2003). Statistical Methods for Rates and Proportions (3rd ed.). New York, NY: Wiley

  BACKGROUND

Results Point of Contact

• Title: Adele Campbell
• Organization: Laborie Medical Technologies

ACampbell@laborie.com

16032558251

Study Officials

• Ruth Kirschner-Hermanns, MD

  Rehabilitationszentrum Godeshöhe

  PRINCIPAL INVESTIGATOR

• Gérard Amarenco, Prof, M.D.

  Hôpital Tenon AP-HP, Sorbonne Université

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: There will be no control arm or blinding in this trial or inclusion of a sham or placebo, as it is not applicable to the study design.

Study Record Dates

• First Submitted: June 2, 2020
• First Posted: June 18, 2020
• Study Start: June 16, 2020
• Primary Completion: December 17, 2020
• Study Completion: September 7, 2023
• Last Updated: December 12, 2024
• Results First Posted: September 7, 2022

Record last verified: 2024-11

Locations

FR (1); DE (1)