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

Completed · Not applicable

Conditions studied: Enteral Nutrition

In brief

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.

Key facts

Study ID

NCT03505593

Run by

Envizion Medical Ltd.

People needed

48

Starts

2018-04-28

Expected to finish

2018-08-09

Last updated by the study team

2020-09-10

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• St.Vincent Hospital and Health Care Center, Inc. — Indianapolis, Indiana, United States

Full record on ClinicalTrials.gov

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