Trial Outcomes & Findings for e۰Sense® Catheter Clinical Investigation (NCT NCT04438499)
NCT ID: NCT04438499
Last Updated: 2024-12-12
Results Overview
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.
COMPLETED
NA
61 participants
approximately 60 minutes
2024-12-12
Participant Flow
Participant milestones
| Measure |
Subjects Medically Indicated for a Urodynamics (UDS) Study
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.
eSense 7fr Catheters: A bladder and abdominal catheter are inserted in to the body to measure pressure for urodynamics.
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Overall Study
STARTED
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61
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Overall Study
COMPLETED
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58
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Overall Study
NOT COMPLETED
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3
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Reasons for withdrawal
| Measure |
Subjects Medically Indicated for a Urodynamics (UDS) Study
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.
eSense 7fr Catheters: A bladder and abdominal catheter are inserted in to the body to measure pressure for urodynamics.
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Overall Study
Lack of Efficacy
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3
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Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Subjects Medically Indicated for a Urodynamics (UDS) Study
n=61 Participants
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.
eSense 7fr Catheters: A bladder and abdominal catheter are inserted in to the body to measure pressure for urodynamics.
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|---|---|
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Age, Continuous
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53.9 years
n=61 Participants
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Sex: Female, Male
Female
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48 Participants
n=61 Participants
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Sex: Female, Male
Male
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13 Participants
n=61 Participants
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Region of Enrollment
Germany
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30 Participants
n=61 Participants
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Region of Enrollment
France
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31 Participants
n=61 Participants
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PRIMARY outcome
Timeframe: approximately 60 minutesPopulation: Sensitivity analysis "Intent to treat" population.
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.
Outcome measures
| Measure |
Subjects Medically Indicated for a UDS Study
n=61 Participants
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.
eSense 7fr Single Sensor Bladder Catheter: Urinary and abdominal catheters inserted in to the body to measure pressure for urodynamics.
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|---|---|
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Clinician Safety and Effectiveness Rating of eSense Catheters (Per Patient)
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58 Participants
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SECONDARY outcome
Timeframe: approximately 60 minutesPopulation: sensitivity analysis population
The secondary outcome will be measured by recording the percentage of participants that do not experience a severe complication or a serious adverse event (as defined in the protocol). 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.
Outcome measures
| Measure |
Subjects Medically Indicated for a UDS Study
n=61 Participants
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.
eSense 7fr Single Sensor Bladder Catheter: Urinary and abdominal catheters inserted in to the body to measure pressure for urodynamics.
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|---|---|
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To Report the Percentage of Participants Free From Severe Complication for the Updated e۰Sense Catheters
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61 Participants
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OTHER_PRE_SPECIFIED outcome
Timeframe: approximately 60 minutesAssess user impressions of the updated e۰Sense® 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.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: approximately 60 minutesOutcome 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.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: approximately 60 minutesOutcome 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 e۰Sense® 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.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: approximately 60 minutesOutcome 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 e۰Sense® 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.
Outcome measures
Outcome data not reported
Adverse Events
Subjects Medically Indicated for a Urodynamics (UDS) Study
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Subjects Medically Indicated for a Urodynamics (UDS) Study
n=61 participants at risk
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.
eSense 7fr Catheters: A bladder and abdominal catheter are inserted in to the body to measure pressure for urodynamics.
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|---|---|
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Renal and urinary disorders
Mild discomfort in the urethra
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16.4%
10/61 • Number of events 10 • The duration of each patient's participation was one clinic visit with a follow-up call 3-5 days later, after which their involvement in the study ended.
Referencing the Medical Device Safety Plan Ordinance (MPSV) under German law: Serious Adverse Event - MPSV § 2 (5) English: A serious adverse event (SAE) is any undesired event occurring in a clinical investigation or a performance evaluation study requiring an authorization, which has led, or could have led, or could lead directly or indirectly to the death or severe health impairment of volunteers, users or other persons regardless of whether the event was caused by the medical device.
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Renal and urinary disorders
Mild macrohematuria
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4.9%
3/61 • Number of events 3 • The duration of each patient's participation was one clinic visit with a follow-up call 3-5 days later, after which their involvement in the study ended.
Referencing the Medical Device Safety Plan Ordinance (MPSV) under German law: Serious Adverse Event - MPSV § 2 (5) English: A serious adverse event (SAE) is any undesired event occurring in a clinical investigation or a performance evaluation study requiring an authorization, which has led, or could have led, or could lead directly or indirectly to the death or severe health impairment of volunteers, users or other persons regardless of whether the event was caused by the medical device.
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Gastrointestinal disorders
Diarrhea
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1.6%
1/61 • Number of events 1 • The duration of each patient's participation was one clinic visit with a follow-up call 3-5 days later, after which their involvement in the study ended.
Referencing the Medical Device Safety Plan Ordinance (MPSV) under German law: Serious Adverse Event - MPSV § 2 (5) English: A serious adverse event (SAE) is any undesired event occurring in a clinical investigation or a performance evaluation study requiring an authorization, which has led, or could have led, or could lead directly or indirectly to the death or severe health impairment of volunteers, users or other persons regardless of whether the event was caused by the medical device.
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Renal and urinary disorders
Bleeding upon catheter removal
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1.6%
1/61 • Number of events 1 • The duration of each patient's participation was one clinic visit with a follow-up call 3-5 days later, after which their involvement in the study ended.
Referencing the Medical Device Safety Plan Ordinance (MPSV) under German law: Serious Adverse Event - MPSV § 2 (5) English: A serious adverse event (SAE) is any undesired event occurring in a clinical investigation or a performance evaluation study requiring an authorization, which has led, or could have led, or could lead directly or indirectly to the death or severe health impairment of volunteers, users or other persons regardless of whether the event was caused by the medical device.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place