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

NCT ID: NCT04582708

Last Updated: 2025-10-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 316 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-09
• Study Completion Date: 2024-09-24

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Subjects with NERv's Inline Device Attached

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

Group Type: EXPERIMENTAL

NERv's Inline Device

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

FluidAI Medical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Cleveland Clinic

Cleveland, Ohio, United States

Hamilton General Hospital

Hamilton, Ontario, Canada

Grand River Hospital

Kitchener, Ontario, Canada

St. Michael's Hospital

Toronto, Ontario, Canada

St. Joseph's Health Centre

Toronto, Ontario, Canada

Juravinski Hospital- Hamilton Health Sciences

Hamilton, Ontrario, Canada

King Saud University Medical City

Riyadh, , Saudi Arabia

Countries

United States; Canada; Saudi Arabia

Other Identifiers

CLS0006

Identifier Type: -

Identifier Source: org_study_id