Skip to main content
OpenTrials
Completed

NCT Number: NCT00781248

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Intubation, Nasogastric

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

"Bikur Cholim" Hospital

Jerusalem, Israel

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

NG Shield

Device

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

Primary outcomes

  1. Pain/discomfort levelusing flicker scale (1-10 scale)during indwelling phase

    Time frame: every 30 minutes for 6 hours

  2. safety of device usage

    Time frame: 6 hours

Secondary outcomes

  1. pain/Dicomfort during insertion and removal of the nasogastric tube

    Time frame: at t=0h and t=6h

Sponsors and collaborators

Lead sponsor

Nanovibronix

Industry

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Oct 28, 2008
Registry last updated
Mar 25, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.