Enteral NutritionNCT03505593
Feasibility Study to Evaluate Safety of ENvizion Medical™ ENVUE™ System
A study testing ENVUE System in people with Enteral Nutrition, run by Envizion Medical Ltd. at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Enteral Nutrition
- What is being tested?
- ENVUE System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Apr 2018to 9 Aug 2018
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must be >21 years of age
- Patients must require placement of an enteral feeding tube
- Patients have an endotracheal tube, OR Do not have an endotracheal tube but are sedated (RASS score of -2 or less) and/or obtunded (Glasgow Coma scale of 9-12)
- Patients or legal authorized representative must be able to understand and adhere to all protocol procedures and be willing and able to provide written informed consent
Who cannot join
- Patients must not have a history of:
- Esophageal varices or ulcers
- Upper airway obstruction
- Upper GI stenosis or obstruction
- Trauma involving sinuses, nares face or neck that would prevent nasogastric (NG) or oral tube insertion
- Deformities of the sinus cavities and/or skull base
Show all 9Show fewer
- Esophageal cancer or neoplasm
- Patients must not have a significant concomitant illness that would adversely affect their participation in the study
- Female patients who are pregnant or lactating
Trial locations and contacts
1 site in 1 country.
United States1 site
St.Vincent Hospital and Health Care Center, Inc.
Indianapolis, Indiana, 46260
About this study
Official title: A Feasibility Study to Evaluate the Clinical Safety of ENvizion Medical™ Enteral Feeding Tube Placement Using the ENvizion Medical™ ENVUE™ System in Patients
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.
Read the detailed description
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.
- Conditions
- Enteral Nutrition
- Being tested
- ENVUE System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ENVUE SystemDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| EFT placement using ENVUE System | Experimental | 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. Receives: Device: ENVUE System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During procedure visit
Secondary outcomes (2)
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
Measured: During procedure visit
Number of Retrograde Tube Migration Events
Tube Migration was defined as: Retrograde migration from desired placement position.
Measured: During follow-up visit (20-48 hours post tube placement)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2018
- Study start28 Apr 2018
- Primary completion9 Aug 2018
- Study completion9 Aug 2018
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 Enteral NutritionStudies 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Envizion Medical Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lewis Jacobson, MD, Principal investigator, St.Vincent Hospital and Health Care Center, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03505593
- Sponsor's protocol ID
- NUTRI002
- Status last verified
- Mar 2020
- First submitted
- 9 Apr 2018
- Last updated
- 10 Sep 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Study to Evaluate the Clinical Safety of ENvizion Medical™ Enteral Feeding Tube Placement Using the ENvizion Medical™ ENVUE™ System in Patients
- ClinicalTrials.gov ID
- NCT03505593
- Acronym / sponsor ID
- NUTRI002
- Conditions
- Enteral Nutrition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Envizion Medical Ltd.Industry (pharma, biotech, devices)
- Study start
- 28 Apr 2018 (actual)
- Primary completion
- 9 Aug 2018 (actual)
- Study completion
- 9 Aug 2018 (actual)
- First posted
- 23 Apr 2018 (actual)
- Results
- Posted 10 Sep 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EFT placement using ENVUE System | Experimental | Device: ENVUE SystemPlacement 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. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients must be >21 years of age
- Patients must require placement of an enteral feeding tube
- Patients have an endotracheal tube, OR Do not have an endotracheal tube but are sedated (RASS score of -2 or less) and/or obtunded (Glasgow Coma scale of 9-12)
- Patients or legal authorized representative must be able to understand and adhere to all protocol procedures and be willing and able to provide written informed consent
Key exclusion criteria (9 listed)
- Patients must not have a history of:
- Patients must not have a significant concomitant illness that would adversely affect their participation in the study
- Female patients who are pregnant or lactating
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 |
|---|---|---|
| ENVUE SystemThe 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. | Device | EFT placement using ENVUE System |
Primary outcome
Number of Participants With Successfully Placed Enteral Feeding Tube
Time frame: During procedure visit
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.
2 secondary outcomes
Total Number of Placement Attempts
Time frame: During procedure visit
Number of Retrograde Tube Migration Events
Time frame: During follow-up visit (20-48 hours post tube placement)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Lewis Jacobson, MD principal investigator
St.Vincent Hospital and Health Care Center, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ENVUE System in people with Enteral Nutrition, run by Envizion 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 4 inclusion and 9 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 10 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 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 10 Sep 2020). 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 With Successfully Placed Enteral Feeding Tube (time frame: During procedure visit). 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 10 Sep 2020.