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NCT03505593 · ClinicalTrials.gov registry record · NA

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

A NA study of Enteral Nutrition, sponsored by Envizion Medical.

Completed
Registry status
NA
Development phase
48
Enrollment target
1
Study location

NCT03505593: Completed NA study of Enteral Nutrition, sponsored by Envizion Medical.

NCT03505593 is a NA study of Enteral Nutrition that has completed, run by Envizion Medical. The registered enrollment target is 48 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03505593, a NA study of Enteral Nutrition, has completed, sponsored by Envizion Medical.

COMPLETED
Registry status
NA
Development phase
48 participants
Enrollment target
1
Study location

Study 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.

Primary Outcome

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.

Conditions Studied

Interventions

  • DEVICE ENVUE System

Study Locations (1)

Indiana

  • St.Vincent Hospital and Health Care Center, Inc. - Indianapolis

Trial Details

FieldValue
Enrollment Target 48 participants
Start Date 2018-04-28
Est. Completion 2018-08-09
Phase NA
Envizion Medical

1 total trials

What the finished NCT03505593 record still lists

NCT03505593 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower).

The record links to 1 condition, with Enteral Nutrition appearing as the primary indexed condition, and to 1 intervention - of which ENVUE System is the first listed.

NCT03505593 reports a single indexed study location in Indiana.

Frequently Asked Questions

What is clinical trial NCT03505593 about?

NCT03505593 is a clinical study titled "Feasibility Study to Evaluate Safety of ENvizion Medical™ ENVUE™ System". 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.

What is the current status of trial NCT03505593?

This trial is currently completed. It is a NA study. The enrollment target is 48 participants. The study started on 2018-04-28. Estimated completion is 2018-08-09.

What conditions does trial NCT03505593 study?

This clinical trial studies the following conditions: Enteral Nutrition.

What interventions are being tested in trial NCT03505593?

The interventions under investigation include: ENVUE System (DEVICE).

Who is sponsoring clinical trial NCT03505593?

This trial is sponsored by Envizion Medical, which has 1 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03505593 being conducted?

This trial has 1 study location across Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

How this trial's enrollment target compares

Where NCT03505593's enrollment target sits among peer trials

48 1381st of 2000 higher than 601 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03505593, the US trial registry maintained by the National Library of Medicine. NCT03505593 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.