Urodynamics Clinical Trial
Official title:
e۰Sense® Clinical Investigation: Assessing the Performance, Safety and Usability of e۰Sense® Electronic Catheters for Performing Urodynamic Studies
Verified date | November 2023 |
Source | Laborie Medical Technologies Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 61 |
Est. completion date | September 7, 2023 |
Est. primary completion date | December 17, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 21 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
France | Hôpital Tenon AP-HP (Sorbonne Université) | Paris | |
Germany | Rehabilitationszentrum Godeshöhe | Bonn |
Lead Sponsor | Collaborator |
---|---|
Laborie Medical Technologies Inc. |
France, Germany,
Fleiss, J.L., Levin, B., & Cho Paik, M. (2003). Statistical Methods for Rates and Proportions (3rd ed.). New York, NY: Wiley
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Assess User Impression Based on Subjective Measures | Outcome not included in a priori interim analysis plan as per the protocol. Assess user impressions of the updated e?Sense® catheters compared with their experience using the existing catheters at each site, by evaluating the following subjective measures: ease of use, ease of insertion and removal, ease of securing the catheter, tracing stability, tracing quality , channel subtraction quality, visibility on VUDS (where applicable), catheter stiffness, sensor location, subject tolerance, and overall usability performance.
This exploratory endpoint will be measured by collecting usability data in a questionnaire format. At the end of each clinic day a trained clinical user shall complete the questionnaire. When evaluating the usability of a device, the sponsor feels it's appropriate to use a subjective ordinal scale response while assessing human and device usability factors. |
approximately 60 minutes | |
Other | Asses Subjective Discomfort Levels in the Study Population | Outcome not included in a priori interim analysis plan as per the protocol. Assess subjective subject feedback regarding their discomfort and pain levels. This exploratory endpoint will be measured by collecting subject feedback regarding the level of discomfort and pain experienced during their Urodynamic test using the Numerical Pain Rating Scale (NPRS). Subjects will grade their discomfort/pain on the NPRS from 0 ("No Pain") to 10 ("Worst Pain"). Given the subject population, use of the NPRS is a validated tool in evaluating pain ratings in adults. | approximately 60 minutes | |
Other | Assess Resting Pressures in the Subject Before Urodynamics | Outcome not included in a priori interim analysis plan as per the protocol. This exploratory endpoint will be measured by recording initial resting pressures (in cmH20) using the updated e?Sense® catheters while each subject is positioned in a sitting, standing and supine position, if patient mobility allows. Resting pressures will be recorded on each subjects' CRF 1 during their urodynamics visit. | approximately 60 minutes | |
Other | Assess Resting Pressure at Different Filling and Emptying Volumes | Outcome not included in a priori interim analysis plan as per the protocol. This exploratory endpoint will be measured by recording resting pressures (in cmH20) using the updated e?Sense® catheters during various points of the UDS test as applicable (every 100 mL of filling, MCC, and post-void) at the recorded patient position (sitting, standing, or supine). Patients are to remain in the same position throughout, however supplemental positions can be used (e.g. performing provocative manoeuvres). Resting pressures and patient position will be recorded on each subjects' CRF 1 during their urodynamics visit. | approximately 60 minutes | |
Primary | 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 e?Sense® 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 e?Sense® 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 | To Report the Severe Complication-free Rate for the Updated e?Sense 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 e?Sense® catheter technology. | approximately 60 minutes |
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