NCT04253028

Use of NERv's Inline Device as an Early Diagnostic Method for Anastomotic Leak.

Use of NERv's Inline Device for the Continuous Monitoring of pH and Conductance Measurements as an Early Diagnostic Method for Anastomotic Leak.

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: FluidAI Medical · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

NERv's early feasibility clinical trial is a first-in-human, multi-center, pre-market, non-randomized clinical trial intended to evaluate the safety and collect preliminary data necessary for the detection of clinical post-operative anastomotic/intraperitoneal leakages. NERv's Inline Device attaches to existing catheters or peritoneal drains that are currently being used in the medical industry. This allows the device to measure the pH and conductance of intraperitoneal fluids that typically get drained through peritoneal drains. The purpose of NERv's feasibility clinical trial is to collect pH and conductance readings by analyzing peritoneal drainage fluid. Upon analyzing data collected from NERv's Inline Device a clinical model of pH and conductance will be created. The clinical model can then be used to determine if a complication is developing. For instance, boundaries (reading thresholds) can be established where if the signal goes outside the boundaries a complication could be identified. Specifically the ability to detect a post-operative complication known as anastomotic leakage; which is a dreaded complication associated with abdominal surgeries; will be the main focus of the study.

Conditions

• Anastomotic Leak

Interventions

Type	Name	Description
DEVICE	NERv's Inline Device	NERv's Inline Device attaches to existing catheters or peritoneal drains that are currently being used in the medical industry. This allows the device to measure the pH and conductance of intraperitoneal fluids that typically get drained through peritoneal drains.

Timeline

• Start date: 2020-01-29
• Primary completion: 2020-03-15
• Completion: 2020-03-15
• First posted: 2020-02-05
• Last updated: 2020-08-12

Locations

2 sites across 1 country: Egypt