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Nutrition Monitoring and Feeding Optimization With the smART+ System - Comparative Study

NCT04098224 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2025-05-29

Study results available
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Summary

The smART+ is a comprehensive modular patient care system intended for ICU patients.

The main purpose of the study is the optimization of the delivery of nutrition.

The use of the smART+ Feeding tube includes a feature of facilitating correct tube placement and alerting when the tube is displaced during ongoing use. The system will automatically stop feeding if displacement is detected. If a massive reflux episode is detected by the system, a balloon located on the tube will automatically inflate and automatic GRV (Gastric Residual Volume) feature will open to prevent gastric content from regurgitating to the esophagus.

In addition to tube placement, the system allows to obtain REE (Resting Energy Expenditure) measurements and calculates the optimized nutritional values required by the patient. Furthermore, the system optimizes feeding by compensating for any lost feeding time or discarded nutritional content that was discarded via the GRV (Gastric Residual Volume).

Study participants will be randomly assigned to a study group:

Group A- ICU patients receiving the investigational device ("Treated"). Group B- Control group.

Conditions

  • Aspiration Pneumonia
  • Malnutrition

Interventions

DEVICE

smART+ System

Utilizing the smART+ System to provide feeding optimization to the patient

Sponsors & Collaborators

  • ART Medical Ltd.

    lead INDUSTRY

Principal Investigators

  • Ilya Kagan, MD · Beilinson Hospital

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-12
Primary Completion
2022-03-10
Completion
2022-11-07

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04098224 on ClinicalTrials.gov