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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.
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Total participants in the "Functionality and Accuracy of the smART System in Real-Life ICU Settings" are 10 participants - in the current Jefferson study site there were 8 participants and in the Sheba study site (identifier NCT03689985) there were 2 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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| General | Experimental | One arm study: smART Feeding Tube System. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| smART Feeding Tube System | Device | Replacing generic feeding tube with smART Feeding Tube System. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants for Whom the System is Able to Accurately Guide and Ensure Correct Initial Feeding Tube Placement , Verified by X-ray | Enrollment visit | |
| Number of Tube "Out of Position" Alerts During Ongoing Use | 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" | Enrollment day up to 7 days |
| Number of Automatic System Generated Feeding Stops in Response to Tube Displacement. | 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 | From insertion of feeding tube up to its removal , an average of 7 days. |
| Number of Major Reflux Event That Lead to Automatically Stops 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):
| From insertion of feeding tube up to its removal , an average of 7 days. |
| Average Duration of Balloon Inflation in Response to a Reflux Episode. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Recording of Impedance Detected by the System and Correlation to Patient Positioning. | 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. | From insertion of feeding tube up to its removal , an average of 7 days. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Thomas Jefferson University Hospital | Philadelphia | Pennsylvania | 19107 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | General | One arm study: smART Feeding Tube System. smART Feeding Tube System: Replacing generic feeding tube with smART Feeding Tube System. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants for Whom the System is Able to Accurately Guide and Ensure Correct Initial Feeding Tube Placement , Verified by X-ray | Posted | Count of Participants | Participants | Enrollment visit |
|
|
3 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | General | One arm study: smART Feeding Tube System. smART Feeding Tube System: Replacing generic feeding tube with smART Feeding Tube System. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute renal failure | Renal and urinary disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mrs Shirly Steinlauf | ART MEDICAL | 972-54-5804242 | shirly@artmedical.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 5, 2018 | Jul 19, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D011015 | Pneumonia, Aspiration |
| ID | Term |
|---|---|
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D008171 | Lung Diseases |
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| From insertion of feeding tube up to its removal , an average of 7 days. |
| 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 | 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) | 56 - 168 hours per patient |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants | No |
|
| Region of Enrollment | Number | participants |
|
|
| Primary | Number of Tube "Out of Position" Alerts During Ongoing Use | 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" | Number of events that system is able to detect tube movement during the study period . | Posted | Number | Out of position alerts | Enrollment day up to 7 days |
|
|
|
| Primary | Number of Automatic System Generated Feeding Stops in Response to Tube Displacement. | 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 | Posted | Number | Number of stops of feeding | From insertion of feeding tube up to its removal , an average of 7 days. |
|
|
|
| Primary | Number of Major Reflux Event That Lead to Automatically Stops 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):
| Each time the system detected massive reflux the system stop the feeding | Posted | Number | Massive reflux episodes | From insertion of feeding tube up to its removal , an average of 7 days. |
|
|
|
| Primary | Average Duration of Balloon Inflation in Response to a Reflux Episode. | 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. | Posted | Mean | Full Range | Minutes | From insertion of feeding tube up to its removal , an average of 7 days. |
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|
|
| Secondary | Recording of Impedance Detected by the System and Correlation to Patient Positioning. | 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. | Posted | Mean | Full Range | position changes | From insertion of feeding tube up to its removal , an average of 7 days. |
|
|
|
| Secondary | 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 | 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) | Posted | Count of Participants | Participants | 56 - 168 hours per patient |
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| 5 |
| 10 |
| Hypothermia | General disorders | Systematic Assessment |
|
| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
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| ARDS | Vascular disorders | Systematic Assessment |
|
| Aspiration pneumonia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Ventricular bigeminy | Cardiac disorders | Systematic Assessment |
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| CHF | Cardiac disorders | Systematic Assessment |
|
| Left femoral deep vein thrombosis | Vascular disorders | Systematic Assessment |
|
| Febrile | General disorders | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | Systematic Assessment |
|
| Colonic ileus | Gastrointestinal disorders | Systematic Assessment |
|
| Fever | General disorders | Systematic Assessment |
|
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| D012140 |
| Respiratory Tract Diseases |