Feasibility Study to Evaluate Safety of Nutriseal™ Nutriplace™ System

NCT03371160 | Terminated Results FDA Device

• 1 other identifier: NUTRI001
• Study Type: interventional
• Target: 22
• 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 Nutriplace™ System guidance during the placement of the Nutriseal™ 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 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.

  During procedure visit

Secondary Outcomes (2)

• Number of Participants Requiring Replacement and/or Repositioning of the Feeding Tube

  During procedure visit

• Number of Participants Reporting Retrograde Tube Migration in the Follow-up Visit

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

Study Arms (1)

Nutriplace™ System

EXPERIMENTAL

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.

Device: Nutriplace™ System

Interventions

Nutriplace™ System DEVICE

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.

Nutriplace™ 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 a nasoenteral 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 Nasogastriv (NG) 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

• Nutriseal L.P: lead

Study Sites (1)

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Results Point of Contact

• Title: Clinical Director
• Organization: ENvizion Medical (Nutriseal)

anath@envizionmed.com

+972-72-2288240

Study Officials

• May Olayan, MD

  The Cleveland Clinic

  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: December 1, 2017
• First Posted: December 13, 2017
• Study Start: December 13, 2017
• Primary Completion: March 15, 2018
• Study Completion: March 15, 2018
• Last Updated: June 18, 2024
• Results First Posted: June 18, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)