NCT04582708

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 316 (actual)
• Sponsor: FluidAI Medical · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Anastomotic Leak
• Fistula
• Postoperative Leak
• Postoperative Pancreatic Fistula
• POPF

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-11-09
• Primary completion: 2024-09-24
• Completion: 2024-09-24
• First posted: 2020-10-09
• Last updated: 2025-10-10

Locations

7 sites across 3 countries: United States, Canada, Saudi Arabia