An interventional study of ENVUE System in Enteral Nutrition, sponsored by Envizion Medical Ltd.. Completed at 1 site in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2020-09-10.
Sponsored by Envizion Medical Ltd. · Not applicable, Interventional, and Supportive care
This is a single center, non-randomized feasibility clinical evaluation that is designed to affirm the safety of the ENVUE™ System guidance during the placement of the ENvizion Medical™ enteral feeding tubes.
Enteral nutrition is the preferred route for the provision of nutritional support in most critical ill patients with functional gastrointestinal tract. Achieving early enteral nutrition (EN) in critically ill patients is associated with fewer major complications, reduced mortality and length of hospital stay, and significant cost savings. It is estimated that approximately 1.2 million feeding tubes are placed blindly each year in the United States alone. Despite the obvious advantages of the enteral tube feeding, inadvertent placement of Enteral Feeding Tube (EFT) into the airway is relatively common and can result in significant pulmonary injury including pneumothorax and pneumonia. Airway misplacement occurs in 1.2- 4 % of blind EFT insertions, with 0.2 to 1.2% of all the feeding tube placements cause pulmonary complications to patients. The gold standard for detecting inadvertent placement of a feeding tube in the lungs is radiography. However, because of its cost, possible delay of feedings while waiting for radiography, and risk for radiation exposure, clinicians continue to seek for alternative methods to confirm correct placement.
All the above mentioned, emphasizes the fact that safe and effective delivery of nasoenteral tube feedings requires assurance that the feeding tube tip is in a proper position. The ENVUE™ System is an electromagnetic tracking system which tracks the path of the feeding tube during placement. The benefit of the system when EFT is misdirected into the pulmonary system is a real-time visual tracing, which may prompt users to withdraw the tube and reinsert it.
This is the only study on the registry with Envizion Medical Ltd. as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients must not have a history of:
Placement of the ENvizion Medical™ Enteral Feeding Tube (EFT) in the stomach or small intestine of adult patients who require feedings via the oro/ nasoenteric route, using the ENVUE™ System.
Device: ENVUE System
The ENvizion Medical™ ENVUE™ System is designed to aid qualified operators in the placement of the ENvizion Medical™ Enteral Feeding Tube™ into the stomach or small intestine.
Number of Participants With Successfully Placed Enteral Feeding Tube
Enteral tube (EFT) can be placed in the correct anatomical position without occurrence of guidance-related adverse events. Procedure success was evaluated by comparing tube tip location according to the ENVUE System and abdominal and/or thoracic X-Ray. Guidance-related AEs were evaluated through the documentation of any guidance-related serious adverse events (SAE) or adverse events (AE) occurring during a subject's participation in the study.
Time frame: During procedure visit
Total Number of Placement Attempts
Number of placement attempts was evaluated by number of replacement and repositioning events, as defined below: * Replacement: Complete removal of the tube from the patient or retraction above the level of the pharynx followed by reinsertion * Repositioning: Changing position of tube without complete removal of the tube
Time frame: During procedure visit
Number of Retrograde Tube Migration Events
Tube Migration was defined as: Retrograde migration from desired placement position.
Time frame: During follow-up visit (20-48 hours post tube placement)
| Milestone | EFT Placement Using ENVUE System |
|---|---|
| Started | 48 |
| Completed | 43 |
| Not completed | 5 |
| Withdrew: Withdrawal by subject | 1 |
| Withdrew: Died before procedure | 1 |
| Withdrew: Anatomical abnormality | 1 |
| Withdrew: Unable to pass through esophagus | 1 |
| Withdrew: Obstruction by endotracheal tube | 1 |
Enteral tube (EFT) can be placed in the correct anatomical position without occurrence of guidance-related adverse events. Procedure success was evaluated by comparing tube tip location according to the ENVUE System and abdominal and/or thoracic X-Ray. Guidance-related AEs were evaluated through the documentation of any guidance-related serious adverse events (SAE) or adverse events (AE) occurring during a subject's participation in the study.
| Participants | EFT Placement Using ENVUE System |
|---|---|
| Number of Participants With Successfully Placed Enteral Feeding Tube | 43 |
Number of placement attempts was evaluated by number of replacement and repositioning events, as defined below: * Replacement: Complete removal of the tube from the patient or retraction above the level of the pharynx followed by reinsertion * Repositioning: Changing position of tube without complete removal of the tube
| Number of placement attempts | EFT Placement Using ENVUE System |
|---|---|
| Total Number of Placement Attempts | 49 |
Tube Migration was defined as: Retrograde migration from desired placement position.
| Number of tube retrograde migration | EFT Placement Using ENVUE System |
|---|---|
| Number of Retrograde Tube Migration Events | 3 |
Collected over From the participant's tube placement procedure (day 0) to the end of of the follow-up visit (20-48 hours post tube placement). Non-serious events are listed at a 2% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| EFT Placement Using ENVUE System | 1/48 (2.1%) | 0/48 (0%) | 1/48 (2.1%) |
| Event | EFT Placement Using ENVUE System |
|---|---|
| Enteral feeding tube distal tip deattachementProduct Issues | 1/48 |
| Age, Continuous(years) | EFT Placement Using ENVUE System |
|---|---|
| Median | 67 (28 to 88) |
| Sex: Female, Male(Participants) | EFT Placement Using ENVUE System |
|---|---|
| Female | 16 |
| Male | 27 |
| Race/Ethnicity, Customized(Participants) | EFT Placement Using ENVUE System |
|---|---|
| Black or African American | 3 |
| White | 40 |
| Region of Enrollment(participants) | EFT Placement Using ENVUE System |
|---|---|
| United States | 43 |
| Sedated(Participants) | EFT Placement Using ENVUE System |
|---|---|
| Count of participants | 0 |
| Obtunded(Participants) | EFT Placement Using ENVUE System |
|---|---|
| Count of participants | 5 |
| Endotracheal Tube(Participants) | EFT Placement Using ENVUE System |
|---|---|
| Count of participants | 38 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
This study is completed, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.