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Functionality and Accuracy of the smART System in Real-Life ICU Settings

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03689985
Recruitment Status : Terminated (Due to the company's intent to conduct a new study under a different protocol with the smART+ System which is a more advanced version of the smART System)
First Posted : October 1, 2018
Last Update Posted : September 22, 2020
Sponsor:
Information provided by (Responsible Party):
ART Medical Ltd.

Tracking Information
First Submitted Date  ICMJE September 16, 2018
First Posted Date  ICMJE October 1, 2018
Last Update Posted Date September 22, 2020
Actual Study Start Date  ICMJE November 7, 2018
Actual Primary Completion Date July 17, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 27, 2018)
  • Verify correct tube placement detection by the system [ Time Frame: 56 -168 hours ]
    To verify that the system is able to automatically detect correct tube placement during on-going use. By using an X-ray.
  • Verify correct tube movement detection by the system [ Time Frame: 56 -168 hours ]
    To verify that the system is able to automatically detect tube movement/displacement during on-going use. By comparing the data collected by the system sensors and the marking on the tube.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 2, 2018)
  • Impedance levels [ Time Frame: 56 -168 hours ]
    To record and analyze impedance levels in order to recognize reflux episodes, measured in ohm.
  • Stop feeding [ Time Frame: 56 -168 hours ]
    To verify that the system stops feeding when the tube is misplaced or reflux is detected by comparing the machine state to the nurses' logs.
  • Clinical staff feedback by using a scale from 1 to 5 [ Time Frame: 56 -168 hours ]
    Obtain feedback from clinical staff regarding device usability during use by using a questionnaire filled by the staff members. A Likert scale is used to asses usability of the device based on subjective user experience, where 1 represents negative response and 5 represents a positive response.
  • Reflux episodes in relation to patient position [ Time Frame: 56 -168 hours ]
    To Collect data regarding the occurrence of reflux episodes in relation to patient positioning.
  • Discarded nutritional supplement [ Time Frame: 56 -168 hours ]
    To quantify the amount of discarded nutritional supplement.
  • No damage to esophagus tissue [ Time Frame: 56 -168 hours ]
    To evaluate the esophagus tissue for any damage caused by the smART system by means of performing an endoscopic examination after removing the device.
  • Aspiration of gastric contents by monitoring the contents of the endotracheal tube suction [ Time Frame: 56 -168 hours ]
    To evaluate the effectiveness of the System to reduce aspiration of gastric contents. By monitoring the contents of the endotracheal tube suction.
Original Secondary Outcome Measures  ICMJE
 (submitted: September 27, 2018)
  • Impedance levels [ Time Frame: 56 -168 hours ]
    To record and analyze impedance levels in order to recognize reflux episodes, measured in ohm.
  • Stop feeding [ Time Frame: 56 -168 hours ]
    To verify that the system stops feeding when the tube is misplaced or reflux is detected by comparing the machine state to the nurses' logs.
  • Clinical staff feedback by using a scale from 1 to 5 [ Time Frame: 56 -168 hours ]
    To obtain feedback from clinical staff regarding device usability during use. By using a questionnaire filled by the staff members.
  • Reflux episodes in relation to patient position [ Time Frame: 56 -168 hours ]
    To Collect data regarding the occurrence of reflux episodes in relation to patient positioning.
  • Discarded nutritional supplement [ Time Frame: 56 -168 hours ]
    To quantify the amount of discarded nutritional supplement.
  • No damage to esophagus tissue [ Time Frame: 56 -168 hours ]
    To evaluate the esophagus tissue for any damage caused by the smART system by means of performing an endoscopic examination after removing the device.
  • Aspiration of gastric contents by monitoring the contents of the endotracheal tube suction [ Time Frame: 56 -168 hours ]
    To evaluate the effectiveness of the System to reduce aspiration of gastric contents. By monitoring the contents of the endotracheal tube suction.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Functionality and Accuracy of the smART System in Real-Life ICU Settings
Official Title  ICMJE Functionality and Accuracy of the smART System in Real-Life ICU Settings
Brief Summary

Total participants in the "Functionality and Accuracy of the smART System in Real-Life ICU Settings" are 10 participants - in the current Sheba study site there were 2 participants and in the Jefferson study site (identifier NCT03198988) there were 8 participants.

This study is conducted in order to validate the functionality and accuracy of the smART™ System in a real-life ICU setting. The smART™ Feeding Tube System is a novel system with nasogastric tube developed by ART Medical (Healthcare) Ltd, based on sensor-lined tubes that transmit real-time information to an external console. The smART™ feeding tube is equipped with reflux sensors which alert when gastric contents regurgitating into the esophagus. In addition, the smART™ 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 smART™ 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, smART™ Feeding Tube System can guide operator to correctly re-position the tube. Lastly the smART™ Feeding Tube System is equipped with an anti-reflux mechanism and automatic Gastric Residual Volume (GRV).

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Aspiration Pneumonia
Intervention  ICMJE Device: smART Feeding Tube System
Replacing generic feeding tube with smART Feeding Tube System.
Study Arms  ICMJE Experimental: General
One arm study: smART Feeding Tube System.
Intervention: Device: smART Feeding Tube System
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: September 21, 2020)
2
Original Estimated Enrollment  ICMJE
 (submitted: September 27, 2018)
15
Actual Study Completion Date  ICMJE July 17, 2020
Actual Primary Completion Date July 17, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

  • Patients with anomalies or diseases of the esophagus and or stomach.
  • Patients with known sensitivities or allergies to any of the feeding tube materials
  • Inability to place patient in 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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03689985
Other Study ID Numbers  ICMJE CRO-B-2479
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party ART Medical Ltd.
Study Sponsor  ICMJE ART Medical Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Yael Haviv-Yadid, Dr. Sheba Medical Center
Principal Investigator: Pierre Singer, Prof. Belinson Hospital
PRS Account ART Medical Ltd.
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP