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

• ClinicalTrials.gov Identifier: NCT03689985
• Recruitment Status: Terminated
• First Posted: October 1, 2018
• Last Update Posted: September 22, 2020
• Sponsor: ART Medical Ltd.
• Information provided by (Responsible Party): ART Medical Ltd.

Tracking Information

• First Submitted Date: September 16, 2018
• First Posted Date: October 1, 2018
• Last Update Posted Date: September 22, 2020
• Actual Study Start Date: November 7, 2018
• Actual Primary Completion Date: July 17, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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 (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: Functionality and Accuracy of the smART System in Real-Life ICU Settings
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Prevention
• Condition: Aspiration Pneumonia

Intervention

Device: smART Feeding Tube System

Replacing generic feeding tube with smART Feeding Tube System.

Study Arms

Experimental: General

One arm study: smART Feeding Tube System.

Intervention: Device: smART Feeding Tube System

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: September 21, 2020): 2
• Original Estimated Enrollment (submitted: September 27, 2018): 15
• Actual Study Completion Date: July 17, 2020
• Actual Primary Completion Date: July 17, 2020 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Israel

Administrative Information

• NCT Number: NCT03689985
• Other Study ID Numbers: 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: Not Provided
• Responsible Party: ART Medical Ltd.
• Study Sponsor: ART Medical Ltd.
• Collaborators: Not Provided

Investigators

• 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