Trial Outcomes & Findings for Feasibility Study to Evaluate Safety of Nutriseal™ Nutriplace™ System (NCT NCT03371160)

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 NUTRIPLACE 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

TERMINATED

Study phase

NA

Target enrollment

22 participants

Primary outcome timeframe

During procedure visit

Results posted on

2024-06-18

Participant Flow

Participant milestones

Participant milestones
Measure	Nutriplace™ System Placement of the Nutriseal™ Enteral Feeding Tube in the stomach or small intestine of adult patients who require feedings via the oro/nasoenteric route, using the Nutriplace™ System. Nutriplace™ System: The Nutriseal™ Nutriplace™ System is designed to aid qualified operators in the placement of the Nutriseal™ Enteral Feeding Tube™ into the stomach or small intestine.
Overall Study STARTED	22
Overall Study Completed Data Collection of Primary Endpoint	14
Overall Study COMPLETED	14
Overall Study NOT COMPLETED	8

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Feasibility Study to Evaluate Safety of Nutriseal™ Nutriplace™ System

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Nutriplace™ System n=22 Participants Placement of the Nutriseal™ Enteral Feeding Tube in the stomach or small intestine of adult patients who require feedings via the oro/nasoenteric route, using the Nutriplace™ System. Nutriplace™ System: The Nutriseal™ Nutriplace™ System is designed to aid qualified operators in the placement of the Nutriseal™ Enteral Feeding Tube™ into the stomach or small intestine.
Age, Continuous	62.5 years n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	5 Participants n=5 Participants
Race/Ethnicity, Customized White	17 Participants n=5 Participants
Region of Enrollment United States	22 Participants n=5 Participants

PRIMARY outcome

Timeframe: During procedure visit

Population: Of 22 enrolled participants, 19 met inclusion/ exclusion criteria and underwent a tube placement attempt. From these 22 participants, 14 completed a successful tube placement using the ENvue system. The study was halted pre-maturely due to a very low enrollment rate at the site.

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 NUTRIPLACE 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	Nutriplace™ System n=22 Participants Placement of the Nutriseal™ Enteral Feeding Tube in the stomach or small intestine of adult patients who require feedings via the oro/nasoenteric route, using the Nutriplace™ System. Nutriplace™ System: The Nutriseal™ Nutriplace™ System is an electromagnetic tracking system for feeding tube placement designed to aid qualified operators in the placement of the Nutriseal™ Enteral Feeding Tube™ into the stomach or small intestine.
Number of Participants With Successfully Placed Enteral Feeding Tube	14 Participants

SECONDARY outcome

Timeframe: During procedure visit

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	Nutriplace™ System n=14 Participants Placement of the Nutriseal™ Enteral Feeding Tube in the stomach or small intestine of adult patients who require feedings via the oro/nasoenteric route, using the Nutriplace™ System. Nutriplace™ System: The Nutriseal™ Nutriplace™ System is an electromagnetic tracking system for feeding tube placement designed to aid qualified operators in the placement of the Nutriseal™ Enteral Feeding Tube™ into the stomach or small intestine.
Number of Participants Requiring Replacement and/or Repositioning of the Feeding Tube	10 Participants

SECONDARY outcome

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

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

Outcome measures

Outcome measures
Measure	Nutriplace™ System n=12 Participants Placement of the Nutriseal™ Enteral Feeding Tube in the stomach or small intestine of adult patients who require feedings via the oro/nasoenteric route, using the Nutriplace™ System. Nutriplace™ System: The Nutriseal™ Nutriplace™ System is an electromagnetic tracking system for feeding tube placement designed to aid qualified operators in the placement of the Nutriseal™ Enteral Feeding Tube™ into the stomach or small intestine.
Number of Participants Reporting Retrograde Tube Migration in the Follow-up Visit	1 Participants

Adverse Events

Nutriplace™ System

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Clinical Director

ENvizion Medical (Nutriseal)

Phone: +972-72-2288240

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee There IS an agreement between the Principal Investigator and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. 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