Status:
COMPLETED
Safety and Efficacy Study of the NG Shield, a Device Intended to Reduce Pain and Discomfort Level Related to Nasogasstric Tube Usage
Lead Sponsor:
Nanovibronix
Conditions:
Intubation, Nasogastric
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 in...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2008
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00781248
Start Date
September 1 2008
End Date
December 1 2008
Last Update
March 25 2009
Active Locations (1)
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1
"Bikur Cholim" Hospital
Jerusalem, Israel