Aspiration PneumoniaNCT02705781
Functionality and Accuracy of the smARTrack System in Real-Life ICU Settings
A study testing smARTrack Feeding Tube System in people with Aspiration Pneumonia, run by ART Medical Ltd. at 1 site in Israel.
Trial summary
This study conducted in order to validate the functionality and accuracy of the smARTrack™ System in a real-life ICU setting. The smARTrack™ Feeding Tube System is a novel system with nasogastric tube developed by ART Healthcare Ltd, based on sensor-lined tubes that transmit real-time information to an external… 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?
- smARTrack Feeding Tube System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteIsrael
- Study dates
- 23 Mar 2016to 14 Aug 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 PPI therapy
- Informed consent by independent physician and next of kin
- ICU ventilated patients
Who cannot join
- Patients with anomalies or diseases of the nose, throat, or esophagus and or stomach.
- Patients with known sensitivities or allergies to any of the feeding tube materials
- Inability to place patient is 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.
About this study
This study conducted in order to validate the functionality and accuracy of the smARTrack™ System in a real-life ICU setting. The smARTrack™ Feeding Tube System is a novel system with nasogastric tube developed by ART Healthcare Ltd, based on sensor-lined tubes that transmit real-time information to an external console. The smARTrack™ feeding tube is equipped with reflux sensors which alert when gastric contents regurgitating into the esophagus. In addition, the smARTrack™ 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 smARTrack™ 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, smARTrack™ Feeding Tube System can guide operator to correctly re-position the tube.
- Conditions
- Aspiration Pneumonia
- Being tested
- smARTrack 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.
smARTrack Feeding Tube SystemDevice
| Study group | Role | What they receive |
|---|---|---|
| General | Experimental | One arm study: smARTrack Feeding Tube System. Receives: Device: smARTrack Feeding Tube System |
What is being measured
The primary outcome is the main question the study is designed to answer.
System accurately guides correct initial placement
The system is able to accurately guide the user to ensure correct initial placement (verified by X-ray)
Measured: 24-72 hours
System accurately detects tube movement/displacement during ongoing use
The system is able to detect tube movement/displacement during ongoing use (verified by markings on the tube)
Measured: 24-72 hours
System automatically stops feeding when displacement is detected
The system automatically stops feeding when tube displacement is detected
Measured: 24-72 hours
System is able to detect overfeeding
The system is able to detect overfeeding
Measured: 24-72 hours
Occurrence of device related Adverse Events (Safety)
Occurrence of device related adverse events
Measured: 24-72 hours
Secondary outcomes (5)
The system user interface is easy for use
Ease of use of the system and the user interface by subjective questionnaire of staff
Measured: 24-72 hours
Correlation of impedance detected to patient positioning
Recording of impedance detected by the system and correlation to patient positioning
Measured: 24-72 hours
Quantification of the amount of discarded nutritional supplement by implementing GRV test
Quantification of the amount of discarded nutritional supplement by implementing GRV test as needed and according to hospital procedures
Measured: 24-72 hours
Aspiration of gastric contents percentage compared to standard feeding (as reported in literature)
Reduction of aspiration of gastric contents percentage compared to standard feeding (as reported in literature).
Measured: 24-72 hours
Correlation between patient clinical information and the occurrence of reflux and sensors data
Correlation between patient clinical information and the occurrence of reflux and sensors data.
Measured: 24-72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2016 (estimated)
- Study start23 Mar 2016
- Primary completion8 Nov 2017
- Study completion14 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 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
- NCT02705781
- Sponsor's protocol ID
- EXC_SYT_P001
- Status last verified
- Sep 2020
- First submitted
- 9 Feb 2016
- Last updated
- 22 Sep 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functionality and Accuracy of the smARTrack System in Real-Life ICU Settings
- ClinicalTrials.gov ID
- NCT02705781
- Acronym / sponsor ID
- EXC_SYT_P001
- Conditions
- Aspiration Pneumonia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- ART Medical Ltd.Industry (pharma, biotech, devices)
- Study start
- 23 Mar 2016 (actual)
- Primary completion
- 8 Nov 2017 (actual)
- Study completion
- 14 Aug 2018 (actual)
- First posted
- 11 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study conducted in order to validate the functionality and accuracy of the smARTrack™ System in a real-life ICU setting. The smARTrack™ Feeding Tube System is a novel system with nasogastric tube developed by ART Healthcare Ltd, based on sensor-lined tubes that transmit real-time information to an external console. The smARTrack™ feeding tube is equipped with reflux sensors which alert when gastric contents regurgitating into the esophagus. In addition, the smARTrack™ 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 smARTrack™ 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, smARTrack™ Feeding Tube System can guide operator to correctly re-position the tube.
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: smARTrack Feeding Tube SystemOne arm study: smARTrack 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 PPI therapy
- Informed consent by independent physician and next of kin
Key exclusion criteria (6 listed)
- Patients with anomalies or diseases of the nose, throat, or esophagus and or stomach.
- Patients with known sensitivities or allergies to any of the feeding tube materials
- Inability to place patient is 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 |
|---|---|---|
| smARTrack Feeding Tube System | Device | General |
Primary outcome
System accurately guides correct initial placement
Time frame: 24-72 hours
The system is able to accurately guide the user to ensure correct initial placement (verified by X-ray)
System accurately detects tube movement/displacement during ongoing use
Time frame: 24-72 hours
The system is able to detect tube movement/displacement during ongoing use (verified by markings on the tube)
System automatically stops feeding when displacement is detected
Time frame: 24-72 hours
The system automatically stops feeding when tube displacement is detected
System is able to detect overfeeding
Time frame: 24-72 hours
The system is able to detect overfeeding
Occurrence of device related Adverse Events (Safety)
Time frame: 24-72 hours
Occurrence of device related adverse events
5 secondary outcomes
The system user interface is easy for use
Time frame: 24-72 hours
Correlation of impedance detected to patient positioning
Time frame: 24-72 hours
Quantification of the amount of discarded nutritional supplement by implementing GRV test
Time frame: 24-72 hours
Aspiration of gastric contents percentage compared to standard feeding (as reported in literature)
Time frame: 24-72 hours
Correlation between patient clinical information and the occurrence of reflux and sensors data
Time frame: 24-72 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2020.
Related trials for Aspiration Pneumonia
Recruiting
The Effects of Wintergreen Essential Oil Inhalation on Alleviating Dyspnea Among Patients With Pneumonia
Pneumonia, Dyspnea
RecruitingPhase 1/2
CaspoNEB: Efficacy and Safety of Caspofungin Aerosols for the Curative Treatment of Pneumocystis Pneumonia
Pneumocystis Pneumonia, Pneumocystis Jirovecii Infection
RecruitingPhase 4
Gastrointestinal Dysmotility on Aspiration Risk
Esophageal Motility Disorders, Gastric Motor Dysfunction
Not yet recruitingObservational study
Surveillance of Neonatal Endotracheal Tube Colonisation
Ventilation, Mechanical, Ventilation-Associated Pneumonia
Not yet recruiting
Oropharyngeal Flushing Suction Tube With Laryngoscope for Stroke-Associated Pneumonia
Acute Ischemic Stroke, Stroke-Associated Pneumonia (SAP)
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 smARTrack Feeding Tube System in people with Aspiration Pneumonia, run by ART Medical Ltd. at 1 site in Israel.
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: finished, as of the sponsor's last update on 22 Sep 2020. 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 Israel. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
System accurately guides correct initial placement (time frame: 24-72 hours). 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 22 Sep 2020.