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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00781248
Recruitment Status : Completed
First Posted : October 28, 2008
Last Update Posted : March 25, 2009
Sponsor:
Information provided by:

Study Description
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

Condition or disease Intervention/treatment Phase
Intubation, Nasogastric Device: NG Shield Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Official Title: Evaluation of Safety and Efficacy of the NasoGastric Shield (NG Shield) in Healthy Subjects With Indwelling Nasogastric Tube
Study Start Date : September 2008
Primary Completion Date : November 2008
Study Completion Date : December 2008
Arms and Interventions

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


Outcome Measures

Primary Outcome Measures :
  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 Outcome Measures :
  1. pain/Dicomfort during insertion and removal of the nasogastric tube [ Time Frame: at t=0h and t=6h ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00781248


Locations
Israel
"Bikur Cholim" Hospital
Jerusalem, Israel
Sponsors and Collaborators
Nanovibronix
Investigators
Principal Investigator: Shmuel Adler, M.D "Bikur Cholim" Hospital, Jerusalem ISRAEL
More Information

Responsible Party: Dr. Dagan Harris VP Clinical Affairs, NanoVibronix
ClinicalTrials.gov Identifier: NCT00781248     History of Changes
Other Study ID Numbers: NV-NGS-06-001
First Posted: October 28, 2008    Key Record Dates
Last Update Posted: March 25, 2009
Last Verified: March 2009

Keywords provided by Nanovibronix:
enteral feeding
Subject who requires nasogastric tube