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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
316
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.
Cleveland Clinic
Cleveland, Ohio, United States
Hamilton General Hospital
Hamilton, Ontario, Canada
Grand River Hospital
Kitchener, Ontario, Canada
St. Michael's Hospital
Toronto, Ontario, Canada
St. Joseph's Health Centre
Toronto, Ontario, Canada
Juravinski Hospital- Hamilton Health Sciences
Hamilton, Ontrario, Canada
King Saud University Medical City
Riyadh, Saudi Arabia
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
Time frame: 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
Time frame: 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
Time frame: The total number of device related adverse events will be established once the study is completed (up to 18 months)
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.
Time frame: 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.
Time frame: 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
Time frame: The economic benefit of using NERv's Inline Device will be established once the study is completed (up to 18 months)
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