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

March 24, 2009 updated by: Nanovibronix

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

24

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Jerusalem, Israel
        • "Bikur Cholim" Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
starting with active NG Shield
Device: NG Shield
A device to reduce pain/discomfort related to nasogastric tube usage
Experimental: 2
Starting with inactive NG Shield
Device: NG Shield
A device to reduce pain/discomfort related to nasogastric tube usage

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nanovibronix

Investigators

  • Principal Investigator: Shmuel Adler, M.D, "Bikur Cholim" Hospital, Jerusalem ISRAEL

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2008

Primary Completion (Actual)

November 1, 2008

Study Completion (Actual)

December 1, 2008

Study Registration Dates

First Submitted

October 26, 2008

First Submitted That Met QC Criteria

October 27, 2008

First Posted (Estimate)

October 28, 2008

Study Record Updates

Last Update Posted (Estimate)

March 25, 2009

Last Update Submitted That Met QC Criteria

March 24, 2009

Last Verified

March 1, 2009

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • NV-NGS-06-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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