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

Anastomotic Leak Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04582708
• Other study ID #: CLS0006
• Status: Recruiting
• Phase: Phase 2
• Start date: November 9, 2020
• Est. completion date: August 15, 2024

Study information

• Verified date: February 2024
• Source: FluidAI Medical
• Contact: Dr. Joao Rezende-Neto, MD, FRCSC, FACS, PhD
• Phone: 4168646060
• Email: RezendeNetoJ[@]smh.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 326
• Est. completion date: August 15, 2024
• Est. primary completion date: August 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anastomotic Leak
• Postoperative Complications

Intervention

Device:
• NERv's Inline Device
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.

Locations

Country	Name	City	State
Canada	Hamilton General Hospital	Hamilton	Ontario
Canada	Juravinski Hospital- Hamilton Health Sciences	Hamilton	Ontrario
Canada	Grand River Hospital	Kitchener	Ontario
Canada	St. Joseph's Health Centre	Toronto	Ontario
Canada	St. Michael's Hospital	Toronto	Ontario
Saudi Arabia	King Saud University Medical City	Riyadh
United States	Cleveland Clinic	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
FluidAI Medical

Countries where clinical trial is conducted

United States,  Canada,  Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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	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)
Secondary	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)
Secondary	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)