N/A
N=48
Feasibility Study to Evaluate Safety of ENvizion Medical™ ENVUE™ System
Enteral Nutrition
Bottom Line
View on ClinicalTrials.gov: NCT03505593 ↗Enrolled (actual)
48
Serious AEs
0.0%
Results posted
Sep 2020
Primary outcome: Primary: Number of Participants With Successfully Placed Enteral Feeding Tube — 43 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- ENVUE System (Device)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Envizion Medical Ltd.
- Primary completion
- Aug 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Successfully Placed Enteral Feeding Tube |
43 | — |
| SECONDARY Total Number of Placement Attempts |
49 | — |
| SECONDARY Number of Retrograde Tube Migration Events |
3 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
- 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
Data sourced from ClinicalTrials.gov (NCT03505593). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.