NCT02705781

Brief Summary

This study conducted in order to validate the functionality and accuracy of the smARTrack™ System in a real-life ICU setting. The smARTrack™ Feeding Tube System is a novel system with nasogastric tube developed by ART Healthcare Ltd, based on sensor-lined tubes that transmit real-time information to an external console. The smARTrack™ feeding tube is equipped with reflux sensors which alert when gastric contents regurgitating into the esophagus. In addition, the smARTrack™ feeding tube is equipped with sensors designed to provide information about the location of the tube thus assisting in reducing the incident of misplacement during first positioning. The smARTrack™ feeding tube is also automatically and in real-time stops feeding if the feeding tube moves out of position during ongoing use or detect gastric content in esophagus. Furthermore, smARTrack™ Feeding Tube System can guide operator to correctly re-position the tube.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 9, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 11, 2016

Completed
12 days until next milestone

Study Start

First participant enrolled

March 23, 2016

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 8, 2017

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 14, 2018

Completed
Last Updated

September 22, 2020

Status Verified

September 1, 2020

Enrollment Period

1.6 years

First QC Date

February 9, 2016

Last Update Submit

September 21, 2020

Conditions

Aspiration Pneumonia

Outcome Measures

Primary Outcomes (5)

  • System accurately guides correct initial placement

    The system is able to accurately guide the user to ensure correct initial placement (verified by X-ray)

    24-72 hours

  • System accurately detects tube movement/displacement during ongoing use

    The system is able to detect tube movement/displacement during ongoing use (verified by markings on the tube)

    24-72 hours

  • System automatically stops feeding when displacement is detected

    The system automatically stops feeding when tube displacement is detected

    24-72 hours

  • System is able to detect overfeeding

    The system is able to detect overfeeding

    24-72 hours

  • Occurrence of device related Adverse Events (Safety)

    Occurrence of device related adverse events

    24-72 hours

Secondary Outcomes (5)

  • The system user interface is easy for use

    24-72 hours

  • Correlation of impedance detected to patient positioning

    24-72 hours

  • Quantification of the amount of discarded nutritional supplement by implementing GRV test

    24-72 hours

  • Aspiration of gastric contents percentage compared to standard feeding (as reported in literature)

    24-72 hours

  • Correlation between patient clinical information and the occurrence of reflux and sensors data

    24-72 hours

Study Arms (1)

General

EXPERIMENTAL

One arm study: smARTrack Feeding Tube System.

Device: smARTrack Feeding Tube System

Interventions

smARTrack Feeding Tube SystemDEVICE
General

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Males and females 18 years or older
  • Patient has already been admitted to ICU
  • Patient requires enteral feeding
  • Patients receiving PPI therapy
  • Informed consent by independent physician and next of kin
  • ICU ventilated patients

You may not qualify if:

  • Patients with anomalies or diseases of the nose, throat, or esophagus and or stomach.
  • Patients with known sensitivities or allergies to any of the feeding tube materials
  • Inability to place patient is semi-Fowler's position.
  • Any clinically significant abnormality upon physical examination which may, in the opinion of the investigator, pose difficulty in inserting the feeding tube (e.g. cervical spine disorder)
  • Pregnancy
  • Recent abdominal surgery (less than 30 days)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rambam Health Care Campus

Haifa, 31096, Israel

Location

MeSH Terms

Conditions

Pneumonia, Aspiration

Condition Hierarchy (Ancestors)

PneumoniaRespiratory Tract InfectionsInfectionsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 9, 2016

First Posted

March 11, 2016

Study Start

March 23, 2016

Primary Completion

November 8, 2017

Study Completion

August 14, 2018

Last Updated

September 22, 2020

Record last verified: 2020-09

Locations

IL(1)