Clinical trial NCT04582708: Use of NERv's Inline Device As an Early Diagnostic Method for Postoperative Complications
Official title: Use of NERv's Inline Device for the Continuous Monitoring of PH and Conductivity As an Early Diagnostic Method for Postoperative Complications
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Anastomotic Leak
Lead sponsor: FluidAI Medical
Sponsor class: INDUSTRY
First posted: 2020-10-09
Enrollment: 326
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


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

Primary outcomes:
measure: Change in pH of Peritoneal Fluid
timeFrame: A clinical model of change in pH over time will be established once the study is completed (up to 18 months)
measure: Change in Electrical Conductivity of Peritoneal Fluid
timeFrame: A clinical model of change in electrical conductivity over time will be established once the study is completed (up to 18 months)
measure: Number of Subjects with Device Related Adverse Events
timeFrame: The total number of device related adverse events will be established once the study is completed (up to 18 months)
Secondary outcomes:
measure: Investigator Feedback on Device's Ease of Use
timeFrame: Ease of use and impact on workflow will be established once the study is completed (up to 18 months)
measure: Subject Feedback on Device's Comfort level
timeFrame: Comfort level will be established once the study is completed (up to 18 months)
measure: 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
timeFrame: The economic benefit of using NERv's Inline Device will be established once the study is completed (up to 18 months)
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Hamilton
country: Canada
facility: Hamilton General Hospital
state: Ontario
city: Kitchener
country: Canada
facility: Grand River Hospital
state: Ontario
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
city: Toronto
country: Canada
facility: St. Joseph's Health Centre
state: Ontario
city: Hamilton
country: Canada
facility: Juravinski Hospital- Hamilton Health Sciences
state: Ontrario
city: Riyadh
country: Saudi Arabia
facility: King Saud University Medical City
Study officials:
References: