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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 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04582708
Study type Interventional
Source FluidAI Medical
Contact Dr. Joao Rezende-Neto, MD, FRCSC, FACS, PhD
Phone 4168646060
Email RezendeNetoJ@smh.ca
Status Recruiting
Phase Phase 2
Start date November 9, 2020
Completion date August 15, 2024
View Details
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