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

NCT03505593 | Completed Results FDA Device

• 1 other identifier: NUTRI002
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Enteral Nutrition

Outcome Measures

Primary Outcomes (1)

• 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.

  During procedure visit

Secondary Outcomes (2)

• Total Number of Placement Attempts

  During procedure visit

• Number of Retrograde Tube Migration Events

  During follow-up visit (20-48 hours post tube placement)

Study Arms (1)

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.

Device: ENVUE System

Interventions

ENVUE System DEVICE

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.

EFT placement using ENVUE System

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Envizion Medical Ltd.: lead

Study Sites (1)

St.Vincent Hospital and Health Care Center, Inc.

Indianapolis, Indiana, 46260, United States

Location

Results Point of Contact

• Title: Clinical Director
• Organization: ENvizion Medical

anath@envizionmed.com

+972-72-2288240

Study Officials

• Lewis Jacobson, MD

  St.Vincent Hospital and Health Care Center, Inc.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2018
• First Posted: April 23, 2018
• Study Start: April 28, 2018
• Primary Completion: August 9, 2018
• Study Completion: August 9, 2018
• Last Updated: September 10, 2020
• Results First Posted: September 10, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)