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

Sponsored by:	Nanovibronix
Information provided by:	Nanovibronix
ClinicalTrials.gov Identifier:	NCT00781248

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 II

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Supportive Care, Randomized, Double Blind (Subject, Investigator), Placebo Control, Crossover Assignment, Safety/Efficacy Study
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
Estimated Study Completion Date:	November 2008
Estimated Primary Completion Date:	November 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental starting with active NG Shield	Device: NG Shield A device to reduce pain/discomfort related to nasogastric tube usage
2: Experimental 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:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00781248

Contacts

Contact: Dagan Harris, PhD

dagan@nanovibronix.com

Locations

Israel
"Bikur Cholim" Hospital	Recruiting
Jerusalem, Israel
Contact: Dagan Harris, PhD dagan@nanovibronix.com

Sponsors and Collaborators

Nanovibronix

Investigators

Principal Investigator:

Shmuel Adler, M.D

"Bikur Cholim" Hospital, Jerusalem ISRAEL

More Information

Responsible Party:	NanoVibronix ( Dr. Dagan Harris VP Clinical Affairs )
Study ID Numbers:	NV-NGS-06-001
Study First Received:	October 26, 2008
Last Updated:	October 27, 2008
ClinicalTrials.gov Identifier:	NCT00781248
Health Authority:	Israel: Ministry of Health

Keywords provided by Nanovibronix:

enteral feeding
Subject who requires nasogastric tube

Study placed in the following topic categories:

Pain
Healthy

ClinicalTrials.gov processed this record on January 16, 2009