Use of NERv's Inline Device as an Early Diagnostic Method for Postoperative Complications

Study Overview
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Brief Summary
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NERv's traditional feasibility clinical trial is a multi-center, pre-market, single-arm, and non-randomized trial. This study will involve the retrospective analysis of prospectively collected data. The trial is intended to establish the safety of NERv's Inline Device and collect preliminary data to illustrate the change in pH and electrical conductivity during normal postoperative recovery and in the event of a complication. The purpose of NERv's feasibility study is to establish a clinical model that shows the progressive change in pH and electrical conductivity during a normal post-operative recovery and in the event of an anastomotic leak in colorectal, hepatobiliary (HPB), trauma, and general surgery patients. Upon analyzing data collected from NERv's Inline Device, a clinical model of change in pH and conductivity over time will be created. The clinical model can be used in future stages to determine if a complication is developing. For instance, boundaries (reading thresholds) can be established to detect a complication when readings exceed such boundaries.

Official Title
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Use of NERv's Inline Device for the Continuous Monitoring of pH and Conductivity as an Early Diagnostic Method for Postoperative Complications

Conditions
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Anastomotic Leak

Intervention / Treatment
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* Device: NERv's Inline Device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years - male or female Subject understands and has voluntarily signed and dated Informed Consent Form (ICF) Subjects must be willing to comply with trial requirements Subject has a peritoneal drain, such as Jackson Pratt drain attached post abdominal surgery Exclusion Criteria: Plans that the subject will be discharged in less than 8 hours post-surgery Involvement in the planning and conduct of the clinical investigation Subject is participating in another investigational drug or device study which may interfere with the endpoints of this study NERv's Inline Device does not attach to drain used on the subject

Ages Eligible for Study
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Minimum Age: 18 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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Subjects with NERv's Inline Device Attached<br>This arm contains subjects which will have NERv's Inline Device attached to their peritoneal drain after abdominal surgery. | Device: NERv's Inline Device<br>* NERv's Inline Device is comprised of multiple sensors. It attaches in line to existing catheters or peritoneal drains that are currently approved for medical use. This allows the device to measure the pH and electrical conductivity of effluent fluids that are drained through peritoneal drains.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in pH of Peritoneal Fluid | NERv's Inline Device will be collecting continuous pH measurements of effluent fluid in abdominal surgery patients during normal recovery and in the event of a complication | A clinical model of change in pH over time will be established once the study is completed (up to 18 months) | 
| Change in Electrical Conductivity of Peritoneal Fluid | NERv's Inline Device will be collecting continuous electrical conductivity measurements of effluent fluid in abdominal surgery patients during normal recovery and in the event of a complication | A clinical model of change in electrical conductivity over time will be established once the study is completed (up to 18 months) | 
| Number of Subjects with Device Related Adverse Events | An adverse event assessment will be performed in accordance to ISO 14155 standards to determine the number of device related adverse events | The total number of device related adverse events will be established once the study is completed (up to 18 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Investigator Feedback on Device's Ease of Use | Ease of use and Impact on workflow will be evaluated by collecting responses to a questionnaire that will be filled out by the study team. The study team will evaluate the device's attachment, removal, setup, calibration, and their overall experience with the user interface on NERv's Mobile Application. The study team will be asked to rate their experience on a scale of 1-5, with 1 being very unsatisfied and 5 being very satisfied. | Ease of use and impact on workflow will be established once the study is completed (up to 18 months) | 
| Subject Feedback on Device's Comfort level | Comfort level will be evaluated by collecting responses to a questionnaire that will be filled out by the subject. The subject will evaluate the device's weight, size, design, and their ability to sleep comfortably with the device attached. The subject will be asked to rate their experience on a scale of 1-5, with 1 being very unsatisfied and 5 being very satisfied. | Comfort level will be established once the study is completed (up to 18 months) | 
| Estimate the economic benefit of the early detection of anastomotic leaks by contrasting the time of detection using NERv's Inline Device and Standard of Care | Retrospective data analysis will be performed to estimate the economic benefit of early detection of anastomotic leaks in patients undergoing gastrointestinal procedures by comparing the time of detection using NERv's Inline device and the time of detection using standard of care | The economic benefit of using NERv's Inline Device will be established once the study is completed (up to 18 months) |