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

NCT04606862 | Unknown FDA Device

• 1 other identifier: MMSEP1901
• Study Type: interventional
• Target: 10,000
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Sepsis

Outcome Measures

Primary Outcomes (2)

• In-hospital sepsis prevalence

  Up to 8 weeks

• In-hospital sepsis related 30-day mortality

  30 days

Secondary Outcomes (10)

• In-hospital all-cause 30-day mortality

  30 days

• Hospital length of stay

  Up to 8 weeks

• Hospital re-admission

  Up to 8 weeks

• Time of initial IV fluids administration

  Day 1 to Day 30, or until discharge

• Time of initial vasopressors administration

  Day 1 to Day 30, or until discharge

Study Arms (2)

Investigational Arm

EXPERIMENTAL

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.

Device: Morley Medical Sepsis Software Device

Control Arm

NO INTERVENTION

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.

Interventions

Morley Medical Sepsis Software Device DEVICE

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.

Investigational Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Morley Medical: lead
• Morley Research Consortium: collaborator

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Kiki Diorgu, MD, MBA

CONTACT

4048911750; adiorgu@morleymed.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 21, 2020
• First Posted: October 28, 2020
• Study Start: October 31, 2020
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: October 28, 2020

Record last verified: 2020-10