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

NCT04582708 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 316

Last updated 2025-10-10

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • FluidAI Medical

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-09
Primary Completion
2024-09-24
Completion
2024-09-24

Countries

  • United States
  • Canada
  • Saudi Arabia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04582708 on ClinicalTrials.gov