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

NCT04582708 | Completed Phase 2

• 1 other identifier: CLS0006
• Study Type: interventional
• Target: 316
• Locations: 3 countries
• Sites: 7

Brief 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

Outcome Measures

Primary Outcomes (3)

• Change in pH of Peritoneal Fluid

  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

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

• Change in Electrical Conductivity of Peritoneal Fluid

  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

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

• Number of Subjects with Device Related Adverse Events

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

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

Secondary Outcomes (3)

• Investigator Feedback on Device's Ease of Use

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

• Subject Feedback on Device's Comfort level

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

• 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

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

Study Arms (1)

Subjects with NERv's Inline Device Attached

EXPERIMENTAL

This arm contains subjects which will have NERv's Inline Device attached to their peritoneal drain after abdominal surgery.

Device: NERv's Inline Device

Interventions

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.

Subjects with NERv's Inline Device Attached

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• FluidAI Medical: lead

Study Sites (7)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Hamilton General Hospital

Hamilton, Ontario, L8L 2X2, Canada

Location

Grand River Hospital

Kitchener, Ontario, N2G 1G3, Canada

Location

St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

Location

St. Joseph's Health Centre

Toronto, Ontario, M6R 1B5, Canada

Location

Juravinski Hospital- Hamilton Health Sciences

Hamilton, Ontrario, L8V 1C3, Canada

Location

King Saud University Medical City

Riyadh, Saudi Arabia

Location

MeSH Terms

Conditions

Anastomotic Leak; Fistula

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pathological Conditions, Anatomical

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2020
• First Posted: October 9, 2020
• Study Start: November 9, 2020
• Primary Completion: September 24, 2024
• Study Completion: September 24, 2024
• Last Updated: October 10, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1); US (1); CA (5)