Trial Outcomes & Findings for Feasibility Study to Evaluate Safety of ENvizion Medical™ ENVUE™ System (NCT NCT03505593)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

48 participants

Primary outcome timeframe

During procedure visit

Results posted on

2020-09-10

Participant Flow

Of 48 enrolled participants, 46 met inclusion/ exclusion criteria and underwent a tube placement attempt. From these 46 participants, 43 completed a successful tube placement.

Participant milestones

Participant milestones
Measure	EFT Placement Using ENVUE System 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. 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.
Overall Study STARTED	48
Overall Study COMPLETED	43
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Reasons for withdrawal
Measure	EFT Placement Using ENVUE System 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. 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.
Overall Study Withdrawal by Subject	1
Overall Study Died before procedure	1
Overall Study Anatomical abnormality	1
Overall Study Unable to pass through esophagus	1
Overall Study Obstruction by Endotracheal tube	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	EFT Placement Using ENVUE System n=43 Participants 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. 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.
Age, Continuous	67 years n=5 Participants
Sex: Female, Male Female	16 Participants n=5 Participants
Sex: Female, Male Male	27 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	3 Participants n=5 Participants
Race/Ethnicity, Customized White	40 Participants n=5 Participants
Region of Enrollment United States	43 participants n=5 Participants
Sedated	0 Participants n=5 Participants
Obtunded	5 Participants n=5 Participants
Endotracheal Tube	38 Participants n=5 Participants

PRIMARY outcome

Timeframe: During procedure visit

Population: Subjects who underwent a successful feeding tube placement using the ENvue system

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.

Outcome measures

Outcome measures
Measure	EFT Placement Using ENVUE System n=43 Participants 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.
Number of Participants With Successfully Placed Enteral Feeding Tube	43 Participants

SECONDARY outcome

Timeframe: During procedure visit

Population: 43 subjects underwent a successful feeding tube placement using the ENvue system. In total, 44 tubes were successfully placed- 1 subject pulled the tube out and a new tube was placed instead

Number of placement attempts was evaluated by number of replacement and repositioning events, as defined below: * Replacement: Complete removal of the tube from the patient or retraction above the level of the pharynx followed by reinsertion * Repositioning: Changing position of tube without complete removal of the tube

Outcome measures

Outcome measures
Measure	EFT Placement Using ENVUE System n=43 Participants 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.
Total Number of Placement Attempts	49 Number of placement attempts

SECONDARY outcome

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

Population: 43 subjects underwent a successful feeding tube placement using the ENvue system. Of the Forty- three (43) subjects that completed a successful placement procedure, thirty-six (36) subjects underwent a successful tube tip position check at follow-up visit.

Tube Migration was defined as: Retrograde migration from desired placement position.

Outcome measures

Outcome measures
Measure	EFT Placement Using ENVUE System n=36 Participants 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.
Number of Retrograde Tube Migration Events	3 Number of tube retrograde migration

Adverse Events

EFT Placement Using ENVUE System

Serious events: 0 serious events

Other events: 1 other events

Deaths: 1 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	EFT Placement Using ENVUE System n=48 participants at risk 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.
Product Issues Enteral feeding tube distal tip deattachement	2.1% 1/48 • Number of events 1 • From the participant's tube placement procedure (day 0) to the end of of the follow-up visit (20-48 hours post tube placement) Analysis was performed on all enrolled subjects (48 subjects)

Additional Information

Clinical Director

ENvizion Medical

Phone: +972-72-2288240

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Twelve months following the completion of the study, Investigator may publish the results of the study. Investigator shall provide sponsor advanced copies of any proposed publication sixty days prior to planned publication Sponsor will have sixty days to review the proposed publication.
Publication restrictions are in place

Restriction type: OTHER