CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 100 enrolled
Drug / intervention
smART+ Systemdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04098224
NCT04098224N/ACompleted

Nutrition Monitoring and Feeding Optimization With the smART+ System

ART Medical Ltd.·interventional·Posted Sep 23, 2019·Updated May 29, 2025

In Brief

A clinical study evaluating smART+ System for Aspiration Pneumonia and Malnutrition. Completed, enrolled 100 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesIsrael
Collaborators--

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedSep 23, 2019
Enrollment StartJan 12, 2020
Primary CompletionMar 10, 2022
Study CompletionNov 7, 2022
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 6.8 years ago

Interventions

smART+ Systemdevice

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