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Completed

NCT Number: NCT04582708

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

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.

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Key information

Conditions

Anastomotic Leak Fistula POPF Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Leak Postoperative Pancreatic Fistula

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Hamilton General Hospital, Hamilton, Ontario, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

NERv's Inline Device

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.

Primary outcomes

  1. Change in pH of Peritoneal Fluid

    Time frame: A clinical model of change in pH over time will be established once the study is completed (up to 18 months)

    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

  2. Change in Electrical Conductivity of Peritoneal Fluid

    Time frame: A clinical model of change in electrical conductivity over time will be established once the study is completed (up to 18 months)

    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

  3. Number of Subjects with Device Related Adverse Events

    Time frame: The total number of device related adverse events will be established once the study is completed (up to 18 months)

    An adverse event assessment will be performed in accordance to ISO 14155 standards to determine the number of device related adverse events

Secondary outcomes

  1. Investigator Feedback on Device's Ease of Use

    Time frame: Ease of use and impact on workflow will be established once the study is completed (up to 18 months)

    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.

  2. Subject Feedback on Device's Comfort level

    Time frame: Comfort level will be established once the study is completed (up to 18 months)

    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.

  3. 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

    Time frame: The economic benefit of using NERv's Inline Device will be established once the study is completed (up to 18 months)

    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

Sponsors and collaborators

Lead sponsor

FluidAI Medical

Industry

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Oct 9, 2020
Registry last updated
Oct 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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