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

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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.

Study Description
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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).


Condition or disease Intervention/treatment Phase
Aspiration Pneumonia Device: smART Feeding Tube System Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Functionality and Accuracy of the smART System in Real-Life ICU Settings
Actual Study Start Date : November 7, 2018
Actual Primary Completion Date : July 17, 2020
Actual Study Completion Date : July 17, 2020
Arms and Interventions
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Arm Intervention/treatment
Experimental: General
One arm study: smART Feeding Tube System.
 Device: smART Feeding Tube System
Replacing generic feeding tube with smART Feeding Tube System.


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. Impedance levels [ Time Frame: 56 -168 hours ]
    To record and analyze impedance levels in order to recognize reflux episodes, measured in ohm.

  2. 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.

  3. 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.


  4. 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.

  5. Discarded nutritional supplement [ Time Frame: 56 -168 hours ]
    To quantify the amount of discarded nutritional supplement.

  6. 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.

  7. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03689985


Locations
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Israel
Belinson Hospital
Petah Tikva, Isreal, Israel, 4941492
Sheba Medical Center
Ramat Gan, Israel
Sponsors and Collaborators
ART Medical Ltd.
Investigators
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Principal Investigator: Yael Haviv-Yadid, Dr. Sheba Medical Center
Principal Investigator: Pierre Singer, Prof. Belinson Hospital
More Information
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Responsible Party: ART Medical Ltd.
ClinicalTrials.gov Identifier: NCT03689985    
Other Study ID Numbers: CRO-B-2479
First Posted: October 1, 2018    Key Record Dates
Last Update Posted: September 22, 2020
Last Verified: September 2020

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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
Additional relevant MeSH terms:
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Pneumonia, Aspiration
Pneumonia
Respiratory Tract Infections
 Infections
Lung Diseases
Respiratory Tract Diseases