e۰Sense® Catheter Clinical Investigation

Study Overview
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Brief Summary
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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.

Detailed Description
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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 participation is one clinic visit to receive their already requested UDS test. A follow-up call will be conducted three to five days later to collect adverse event information post-test. An interim analysis is to be performed when data from 30 patients has been completed to support the primary objective, and using the results for regulatory purposes (e.g. CE marking). However, the study enrollment continues, during the interim analysis, until 60 patients (maximum 65) have been recruited and all data collected. At the end of the study, the data will be analysed against secondary and exploratory objectives including an exploratory analysis of the primary objective on all patients. To collect data for the study, Case Report Forms (CRF) have been developed. They will be paper based and do not include any patient identifiers except a Site Subject ID. Any document linking the Site Subject ID to subject information will be stored at the site and not shared with the sponsor. Additionally, CRF completion guidelines will be developed prior to study initiation to aid correct and consistent data collection. These guidelines will be provided to the site and site personnel will be trained prior to subject enrollment. CRFs will be treated as source data in the event that the original information is entered on the CRFs first, and no source document worksheet is utilized for that data point. Laborie will enter CRF data in to an excel database that has been developed to represent each field on the CRF. Data Management activities are conducted in accordance with Laborie's Data Management Plan, including but not limited to: source data verification (monitoring), query handling and resolution, data entry quality control and controlled database locking. Guidelines have also been created that contain detailed descriptions of each data entry point and how to enter in the database. The data from the CRFs will be used to make the following assessments: The investigator will be asked to make an assessment to determine the safety and performance of the device regarding the intended use. A Numeric Pain Rating Scale (NPRS) will be used to assess the parameters of patient discomfort/pain, if appropriate. All adverse events will be recorded to assess the safety of the device. Subjective questionnaire completed by the user to assess ease of use, ease of insertion and removal, ease of securing the catheter, tracing stability (overall, during filling, voiding and UPP where applicable), tracing quality (overall, Pves, Pabd, Pura where applicable), channel subtraction quality, visibility on Video Urodynamics (VUDS, where applicable), catheter stiffness, sensor location, patient tolerance, and overall usability performance. Pre-test at various positions and resting pressures through the study The de-identified urodynamic data files will be collected and stored Risks to the patient will be no greater than those of a standard Urodynamics test. Patients may experience temporary discomfort upon insertion of the catheters. Test duration may be slightly longer than a standard test while assessment of the study materials is being made, and so discomfort and inconvenience associated with an extended test duration may occur. Furthermore, bladder catheterization can increase the risk of urinary tract infection, but with no higher incidence than during standard urodynamics. No patient follow-up visit is scheduled for this study, unless deemed necessary by the physician in the event of adverse event(s). Monitors are appointed by Laborie and are appropriately trained with scientific and/or clinical knowledge needed to monitor the trial adequately. The monitors are also thoroughly familiar with the investigational medical device under investigation, the protocol, written informed consent form (ICF), and any other written information to be provided to subjects, Laborie standard operating procedures, ISO 14155, and GCP. The monitor conducts activities per Laborie's Monitoring Plan, including but not limited to: Acting as the main line of communication between the sponsor and the investigator. Verifying that the investigator has adequate qualifications, number of subjects, and resources and remain adequate throughout the trial period, and that facilities are adequate to safely and properly conduct the trial and remain adequate through the trial period. Initiating each participating sites Ensuring the investigational device is being used according to the protocol and instructions for use Verifying that the investigator and investigation site team understands and follows the approved protocol and all approved amendments (if any). Verifying that the investigator is familiar with the responsibilities of the principal investigator. Ensuring the investigator and site team are informed and knowledgeable of all relevant document updates concerning the clinical trial. Ensuring that the investigator receives the most up-to-date copy of the Investigator's Brochure, all documents, and all trial supplies needed to conduct the trial properly and to comply with the applicable regulatory requirements. Verifying that only authorized and trained site personnel are participating in the clinical trial. Verifying that source data and other records are accurate, complete, up to date, stored, and maintained appropriately. Signed and dated informed consent forms have been obtained from each subject at the point of enrolment or before any clinical-investigation-related procedures are performed. Verifying that CRFs and queries are complete, recorded in a timely manner, and consistent with SD. Verifying that appropriate corrections, additions, or deletions are made to the CRFs, dated, explained if necessary and initiated by the authorized designee. The monitor shall NOT make corrections, additions, or deletions to the CRFs. Ensuring all adverse events (AEs) and device deficiencies (DDs) are reported to the sponsor and all serious AEs as well as DDs that could have led to serious adverse device events are reported to the sponsor without unjustified delay. Verifying that subject withdrawal has been documented and that subject or site non-compliance with the requirements has been documented.

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

Conditions
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Urodynamics

Intervention / Treatment
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* Device: eSense 7fr Single Sensor Bladder Catheter


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model Description: 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Subjects Indicated for a UDS study<br>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<br>* Urinary and abdominal catheters inserted in to the body to measure pressure for urodynamics.<br>* Other names: eSense 7Fr Dual Sensor Urethral Catheters;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To Report the Severe Complication-free Rate for the Updated e۰Sense Catheters. | Outcome not included in a priori interim analysis plan as per the protocol. The secondary outcome will be measured by recording the number of severe complications and serious adverse events (as defined in the protocol) for each subject on their CRF. Due to the low risk profile of UDS, the sponsor would like to report the severe complication-free rate for any severe complications associated with UDS, and therefore this secondary safety endpoint was planned. Additionally, the sponsor would like to collect and assess this information due to a lack of available published data using the e۰Sense® catheter technology. | approximately 60 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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urodynamics, urinary catheter