Safety and Efficacy Study of the NG Shield, a Device Intended to Reduce Pain and Discomfort Level Related to Nasogasstric Tube Usage

Nanovibronix

Status and phase

Completed

Phase 2

Conditions

Intubation, Nasogastric

Treatments

Device: NG Shield

Study type

Interventional

Funder types

Industry

Identifiers

NCT00781248

NV-NGS-06-001

Details and patient eligibility

About

The purpose of the study i to demonstrate the safety and efficacy of a device that intends to reduce pain/discomfort related to nasogfastric tube usage by reducing the friction between the tube and internal orifice (nose and pharynx)using micro vibrations

Enrollment

24 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Subject is in good health and able to undergoes the NG tube insertion procedure, according to the PI decision
Subject is able to understand and answer the pain and discomfort questionnaires
Subject has been fasting for at least 12h prior to the insertion phase
Subject underwent a physical examination by the PI
Subject able, agrees and signs the Inform Consent Form (ICF)

Exclusion criteria

Subject has any history of dysphagia or esophageal disease
Subject used anti pain medications during the last week prior to the study date
Subject used Antibiotics during the last week prior to the study date
Subject with Asthma
Subject with chronic or acute nasal or throat disorder
Subject who suffered from upper respiratory infection at least 7 days prior to the insertion procedure
Any pain from other source prior to the initiation of the study procedure according to the PI judgment and decision
Subject has any condition, which precludes compliance with study and/or device instruction for use
Subject is currently participating in another clinical study