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A Clinical Trial to Evaluate the Efficacy of the Morley Medical Sepsis (MMS) Software Device in Predicting Sepsis in Adult Patients Using Artificial Intelligence (AI) Machine Learning Algorithms

Primary Purpose

Sepsis

Status

Unknown status

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Morley Medical Sepsis Software Device

About this trial

This is an interventional diagnostic trial for Sepsis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Male or female patient 18 years of age or older
Patient is admitted or had been admitted to a participating healthcare facility

Exclusion Criteria:

Sepsis diagnosis present on admission
Involvement in a clinical trial of another investigational product with similar purpose

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Investigational Arm

Control Arm

Arm Description

The patients enrolled into the investigational arm at each participating hospital will be monitored with the Morley Medical Sepsis (MMS) Software Device for the prediction and early identification of sepsis.

The patients enrolled into the control group of each participating hospital will not be monitored with the Morley Medical Sepsis (MMS) Software Device for the prediction and early identification of sepsis. These patients will be monitored according to each institution's standard sepsis screening practices.

Outcomes

Primary Outcome Measures

In-hospital sepsis prevalence

In-hospital sepsis related 30-day mortality

Secondary Outcome Measures

In-hospital all-cause 30-day mortality

Hospital length of stay

Hospital re-admission

Time of initial IV fluids administration

Time of initial vasopressors administration

Time of initial antibiotics administration

Time of initial blood microbiology culture

Sepsis related adverse outcomes (septic shock)

Sepsis prediction to onset time

Sensitivity and specificity of sepsis prediction

Full Information

NCT ID

NCT04606862

First Posted

October 21, 2020

Last Updated

October 27, 2020

Sponsor

Morley Medical

Collaborators

Morley Research Consortium

1. Study Identification

Unique Protocol Identification Number

NCT04606862

Brief Title

A Clinical Trial to Evaluate the Efficacy of the Morley Medical Sepsis (MMS) Software Device in Predicting Sepsis in Adult Patients Using Artificial Intelligence (AI) Machine Learning Algorithms

Official Title

A Non-Randomized Clinical Trial to Investigate the Efficacy of the Morley Medical Sepsis (MMS) Software Device in the Prediction and Early Detection of Sepsis

Study Type

Interventional

2. Study Status

Record Verification Date

October 2020

Overall Recruitment Status

Unknown status

Study Start Date

October 31, 2020 (Anticipated)

Primary Completion Date

December 31, 2020 (Anticipated)

Study Completion Date

December 31, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Morley Medical

Collaborators

Morley Research Consortium

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Device Product Not Approved or Cleared by U.S. FDA

Yes

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

Brief Summary

This is a pivotal medical device clinical trial evaluating the clinical outcomes in hospitalized patients monitored with the Morley Medical Sepsis Software Device. The device uses unique AI machine learning algorithms to analyze patient data in real time and generate clinical decision support sepsis risk predictions for clinicians.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Sepsis

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

This is a pivotal medical device clinical trial comparing the clinical outcomes in hospitalized patients monitored with the MMS Software Device for the prediction and early detection of sepsis versus patients monitored with current standard sepsis scoring systems at participating clinical trial sites. This will be conducted through a non-randomized multi-center, non-blinded, clinical trial.

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

10000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Investigational Arm

Arm Type

Experimental

Arm Description

Arm Title

Control Arm

Arm Type

No Intervention

Arm Description

Intervention Type

Device

Intervention Name(s)

Morley Medical Sepsis Software Device

Intervention Description

The Morley Medical Sepsis (MMS) Software Device is a predictive analytics, stand-alone, cloud-based software system with no hardware components. The software acquires patient data from the electronic medical record, processes the data using unique artificial intelligence (AI) powered algorithms, and generates clinical decision support outputs that aid in the proactive delivery of customized and efficient care for patients. The software output is made available to the end users (trained medical professionals) via an intuitive user interface displayed on desktop computers or mobile communication devices such as laptops, smartphones or tablets.

Primary Outcome Measure Information:

Title

In-hospital sepsis prevalence

Time Frame

Up to 8 weeks

Title

In-hospital sepsis related 30-day mortality

Time Frame

30 days

Secondary Outcome Measure Information:

Title

In-hospital all-cause 30-day mortality

Time Frame

30 days

Title

Hospital length of stay

Time Frame

Up to 8 weeks

Title

Hospital re-admission

Time Frame

Up to 8 weeks

Title

Time of initial IV fluids administration

Time Frame