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

NCT03505593 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2020-09-10

Study results available
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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

Interventions

DEVICE

ENVUE System

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.

Sponsors & Collaborators

  • Envizion Medical Ltd.

    lead INDUSTRY

Principal Investigators

  • Lewis Jacobson, MD · St.Vincent Hospital and Health Care Center, Inc.

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-28
Primary Completion
2018-08-09
Completion
2018-08-09
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03505593 on ClinicalTrials.gov