Trial Outcomes & Findings for Functionality and Accuracy of the smART System in Real-Life ICU Settings (NCT NCT03198988)

Results Overview

Recruitment status

TERMINATED

Target enrollment

10 participants

Primary outcome timeframe

Enrollment visit

Results posted on

2023-02-13

Participant Flow

Participant milestones

Participant milestones
Measure	smART Feeding Tube System The smART™ Feeding Tube System is a novel feeding tube developed by ART Healthcare Ltd. to overcome feeding tube displacement and reflux prevention and the complications associated with them. The smART Feeding Tube is equipped with sensors designed to provide information about the location of the tube tip relative to the lower esophageal sphincter as well as a balloon intended to aid in the prevention of aspiration due to reflux episodes.
Overall Study STARTED	10
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	General n=10 Participants One arm study: smART Feeding Tube System. smART Feeding Tube System: Replacing generic feeding tube with smART Feeding Tube System.
Age, Continuous	53.62 years n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants
Race (NIH/OMB) White	8 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	8 participants n=5 Participants
Region of Enrollment Israel	2 participants n=5 Participants

PRIMARY outcome

Timeframe: Enrollment visit

Outcome measures

Outcome measures
Measure	General n=9 Participants One arm study: smART Feeding Tube System. smART Feeding Tube System: Replacing generic feeding tube with smART Feeding Tube System.
Number of Participants for Whom the System is Able to Accurately Guide and Ensure Correct Initial Feeding Tube Placement , Verified by X-ray	9 Participants

PRIMARY outcome

Timeframe: Enrollment day up to 7 days

Population: Number of events that system is able to detect tube movement during the study period .

Any patient , in which the system alerted of tube out of position , the staff verified this according to the tube markings and if mispositioning occurred, this was documented the event in the CRF "out of position"

Outcome measures

Outcome measures
Measure	General n=9 Participants One arm study: smART Feeding Tube System. smART Feeding Tube System: Replacing generic feeding tube with smART Feeding Tube System.
Number of Tube "Out of Position" Alerts During Ongoing Use	16 Out of position alerts

PRIMARY outcome

Timeframe: From insertion of feeding tube up to its removal , an average of 7 days.

In order to prevent aspiration, the system software automatically pinches the feeding tube. Verification of the functionality of automatic feeding cessation when tube displacement is detected was done as part of the formal verification of the system

Outcome measures

Outcome measures
Measure	General n=9 Participants One arm study: smART Feeding Tube System. smART Feeding Tube System: Replacing generic feeding tube with smART Feeding Tube System.
Number of Automatic System Generated Feeding Stops in Response to Tube Displacement.	16 Number of stops of feeding

PRIMARY outcome

Timeframe: From insertion of feeding tube up to its removal , an average of 7 days.

Population: Each time the system detected massive reflux the system stop the feeding

Overfeeding is the intolerance of the stomach to feeding material that causes reflux. There are two types of reflux events as defined by the system; minor-reflux and massive-reflux. Both types of reflux events are detected by the level of fluids interacting with the sensors, the severity is defined by gastric content reaching above the lower esophageal sphincter (LES): 1. Minor reflux is defined as gastric content that did not pass the balloon located in the center of the esophagus. 2. Massive reflux is defined as gastric content that reaches immediately above the balloon.

Outcome measures

Outcome measures
Measure	General n=9 Participants One arm study: smART Feeding Tube System. smART Feeding Tube System: Replacing generic feeding tube with smART Feeding Tube System.
Number of Major Reflux Event That Lead to Automatically Stops Feeding	709 Massive reflux episodes

PRIMARY outcome

Timeframe: From insertion of feeding tube up to its removal , an average of 7 days.

Massive reflux of gastric content can aspirate into the lungs and cause pneumonia. The system detects the reflux event and will (according to an algorithm) stop the feeding and or inflate a balloon and evacuate gastric residuals from the stomach to lower the risk of aspiration.

Outcome measures

Outcome measures
Measure	General n=9 Participants One arm study: smART Feeding Tube System. smART Feeding Tube System: Replacing generic feeding tube with smART Feeding Tube System.
Average Duration of Balloon Inflation in Response to a Reflux Episode.	6.25 Minutes Interval 0.0 to 87.81

SECONDARY outcome

Timeframe: From insertion of feeding tube up to its removal , an average of 7 days.

Positions changes were correlated to reflux events captured by the system console. Any position change of the patient was captured by the video camera located above the patient's bed.

Outcome measures

Outcome measures
Measure	General n=9 Participants One arm study: smART Feeding Tube System. smART Feeding Tube System: Replacing generic feeding tube with smART Feeding Tube System.
Recording of Impedance Detected by the System and Correlation to Patient Positioning.	46.19 position changes Interval 38.46 to 77.27

SECONDARY outcome

Timeframe: 56 - 168 hours per patient

The first and the last X-ray images obtained for patients during the study were used to evaluate Ventilator Associated Pneumonia (VAP) and/or Acute respiratory distress syndrome (ARDS)

Outcome measures

Outcome measures
Measure	General n=9 Participants One arm study: smART Feeding Tube System. smART Feeding Tube System: Replacing generic feeding tube with smART Feeding Tube System.
Number of Participant With Change in Ventilator Associated Pneumonia (VAP) and/or Acute Respiratory Distress Syndrome (ARDS) as a Measure of Effectiveness in Reducing Aspiration of Gastric Contents Improvement in VAP/ARDS according to X-ray	4 Participants
Number of Participant With Change in Ventilator Associated Pneumonia (VAP) and/or Acute Respiratory Distress Syndrome (ARDS) as a Measure of Effectiveness in Reducing Aspiration of Gastric Contents No VAP/ cannot be estimated	3 Participants
Number of Participant With Change in Ventilator Associated Pneumonia (VAP) and/or Acute Respiratory Distress Syndrome (ARDS) as a Measure of Effectiveness in Reducing Aspiration of Gastric Contents No chance from first and last Xray images is seen	2 Participants

Adverse Events

General

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	General n=10 participants at risk One arm study: smART Feeding Tube System. smART Feeding Tube System: Replacing generic feeding tube with smART Feeding Tube System.
Renal and urinary disorders Acute renal failure	10.0% 1/10 • Number of events 1 • 3 months
General disorders Hypothermia	10.0% 1/10 • Number of events 3 • 3 months
Blood and lymphatic system disorders Anemia	10.0% 1/10 • Number of events 1 • 3 months
Vascular disorders ARDS	10.0% 1/10 • Number of events 1 • 3 months
Respiratory, thoracic and mediastinal disorders Aspiration pneumonia	10.0% 1/10 • Number of events 1 • 3 months
Cardiac disorders Ventricular bigeminy	10.0% 1/10 • Number of events 1 • 3 months
Cardiac disorders CHF	10.0% 1/10 • Number of events 1 • 3 months
Vascular disorders Left femoral deep vein thrombosis	10.0% 1/10 • Number of events 1 • 3 months
General disorders Febrile	10.0% 1/10 • Number of events 1 • 3 months
Gastrointestinal disorders Abdominal distension	10.0% 1/10 • Number of events 1 • 3 months
Gastrointestinal disorders Colonic ileus	10.0% 1/10 • Number of events 1 • 3 months
General disorders Fever	10.0% 1/10 • Number of events 1 • 3 months

Additional Information

Mrs Shirly Steinlauf

ART MEDICAL

Phone: 972-54-5804242

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place