N/A Completed N=48 Supportive Care

Feasibility Study to Evaluate Safety of ENvizion Medical™ ENVUE™ System

Enteral Nutrition

Source: ClinicalTrials.gov NCT03505593 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Sep 2020

Primary outcomePrimary: Number of Participants With Successfully Placed Enteral Feeding Tube — 43 Participants

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.

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	—

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

View full record on ClinicalTrials.gov →

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. Informational only — not medical advice.