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

This study has been completed.
Sponsor:
Information provided by:
Nanovibronix
ClinicalTrials.gov Identifier:
NCT00781248
First received: October 26, 2008
Last updated: March 24, 2009
Last verified: March 2009
  Purpose

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 Intervention Phase
Intubation, Nasogastric
Device: NG Shield
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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

Further study details as provided by Nanovibronix:

Primary Outcome Measures:
  • Pain/discomfort levelusing flicker scale (1-10 scale)during indwelling phase [ Time Frame: every 30 minutes for 6 hours ] [ Designated as safety issue: No ]
  • safety of device usage [ Time Frame: 6 hours ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • pain/Dicomfort during insertion and removal of the nasogastric tube [ Time Frame: at t=0h and t=6h ] [ Designated as safety issue: No ]

Estimated Enrollment: 24
Study Start Date: September 2008
Study Completion Date: December 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Dr. Dagan Harris VP Clinical Affairs, NanoVibronix
ClinicalTrials.gov Identifier: NCT00781248     History of Changes
Other Study ID Numbers: NV-NGS-06-001
Study First Received: October 26, 2008
Last Updated: March 24, 2009
Health Authority: Israel: Ministry of Health

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

ClinicalTrials.gov processed this record on April 17, 2014