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

Morley Medical

Status: Unknown

Conditions: Sepsis

Treatments: Device: Morley Medical Sepsis Software Device

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT04606862

MMSEP1901

Details and patient eligibility

About

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.

Enrollment: 10,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts 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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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10,000 participants in 2 patient groups

Investigational Arm

Experimental group

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.

Treatment:

Device: Morley Medical Sepsis Software Device

Control Arm

No Intervention group

Description:

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.