Aspiration PneumoniaNCT03198988
Functionality and Accuracy of the smART System in Real-Life ICU Settings
A study testing smART Feeding Tube System in people with Aspiration Pneumonia, run by ART Medical Ltd. at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aspiration Pneumonia
- What is being tested?
- smART Feeding Tube System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Oct 2017to 28 Apr 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
About this study
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).
- Conditions
- Aspiration Pneumonia
- Being tested
- smART Feeding Tube System
- Medical subject headings
- Pneumonia, Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
smART Feeding Tube SystemDevice
Replacing generic feeding tube with smART Feeding Tube System.
| Study group | Role | What they receive |
|---|---|---|
| General | Experimental | One arm study: smART Feeding Tube System. Receives: Device: smART Feeding Tube System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants for Whom the System is Able to Accurately Guide and Ensure Correct Initial Feeding Tube Placement , Verified by X-ray
Measured: 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"
Measured: 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
Measured: 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):
- Minor reflux is defined as gastric content that did not pass the balloon located in the center of the esophagus.
- Massive reflux is defined as gastric content that reaches immediately above the balloon.
Measured: 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.
Measured: From insertion of feeding tube up to its removal , an average of 7 days.
Secondary outcomes (2)
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.
Measured: 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)
Measured: 56 - 168 hours per patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2017
- Study start26 Oct 2017
- Primary completion28 Apr 2020
- Study completion28 Apr 2020
Why it stopped: 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.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Aspiration PneumoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- ART Medical Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03198988
- Sponsor's protocol ID
- CLT3_SY_P001
- Status last verified
- Jul 2021
- First submitted
- 12 Jun 2017
- Last updated
- 13 Feb 2023
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functionality and Accuracy of the smART System in Real-Life ICU Settings
- ClinicalTrials.gov ID
- NCT03198988
- Acronym / sponsor ID
- CLT3_SY_P001
- Conditions
- Aspiration Pneumonia
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: 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.
- Enrolment
- 10 participants (actual)
- Lead sponsor
- ART Medical Ltd.Industry (pharma, biotech, devices)
- Study start
- 26 Oct 2017 (actual)
- Primary completion
- 28 Apr 2020 (actual)
- Study completion
- 28 Apr 2020 (actual)
- First posted
- 26 Jun 2017 (actual)
- Results
- Posted 13 Feb 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| General | Experimental | Device: smART Feeding Tube SystemOne arm study: smART Feeding Tube System. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| smART Feeding Tube SystemReplacing generic feeding tube with smART Feeding Tube System. | Device | General |
Primary outcome
Number of Participants for Whom the System is Able to Accurately Guide and Ensure Correct Initial Feeding Tube Placement , Verified by X-ray
Time frame: Enrollment visit
Number of Tube "Out of Position" Alerts During Ongoing Use
Time frame: Enrollment day up to 7 days
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 Automatic System Generated Feeding Stops in Response to Tube Displacement.
Time frame: 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
Number of Major Reflux Event That Lead to Automatically Stops Feeding
Time frame: From insertion of feeding tube up to its removal , an average of 7 days.
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.
Average Duration of Balloon Inflation in Response to a Reflux Episode.
Time frame: 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.
2 secondary outcomes
Recording of Impedance Detected by the System and Correlation to Patient Positioning.
Time frame: 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
Time frame: 56 - 168 hours per patient
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing smART Feeding Tube System in people with Aspiration Pneumonia, run by ART Medical Ltd. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Feb 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants for Whom the System is Able to Accurately Guide and Ensure Correct Initial Feeding Tube Placement , Verified by X-ray (time frame: Enrollment visit). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2023.