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

Evaluation of Safety and Efficacy of the NasoGastric Shield (NG Shield) in Healthy Subjects With Indwelling Nasogastric Tube

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00781248

Enrollment

Registered

2008-10-28

Start date

2008-09-30

Completion date

2008-12-31

Last updated

2009-03-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intubation, Nasogastric

Keywords

enteral feeding, Subject who requires nasogastric tube

Brief summary

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

Interventions

DEVICENG Shield

A device to reduce pain/discomfort related to nasogastric tube usage

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

SUPPORTIVE_CARE

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

1. Subject is in good health and able to undergoes the NG tube insertion procedure, according to the PI decision 2. Subject is able to understand and answer the pain and discomfort questionnaires 3. Subject has been fasting for at least 12h prior to the insertion phase 4. Subject underwent a physical examination by the PI 5. Subject able, agrees and signs the Inform Consent Form (ICF)

Exclusion criteria

1. Subject has any history of dysphagia or esophageal disease 2. Subject used anti pain medications during the last week prior to the study date 3. Subject used Antibiotics during the last week prior to the study date 4. Subject with Asthma 5. Subject with chronic or acute nasal or throat disorder 6. Subject who suffered from upper respiratory infection at least 7 days prior to the insertion procedure 7. Any pain from other source prior to the initiation of the study procedure according to the PI judgment and decision 8. Subject has any condition, which precludes compliance with study and/or device instruction for use 9. Subject is currently participating in another clinical study

Design outcomes

Primary

Measure	Time frame
Pain/discomfort levelusing flicker scale (1-10 scale)during indwelling phase	every 30 minutes for 6 hours
safety of device usage	6 hours

Secondary

Measure	Time frame
pain/Dicomfort during insertion and removal of the nasogastric tube	at t=0h and t=6h

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026