CompletedPhase 2

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

Israel24 participantsStarted 2008-09

Plain-language 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

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Pain/discomfort levelusing flicker scale (1-10 scale)during indwelling phase

Timeframe: every 30 minutes for 6 hours

safety of device usage

Timeframe: 6 hours

Trial details

NCT IDNCT00781248

SponsorNanovibronix

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2008-11

View on ClinicalTrials.gov More Intubation, Nasogastric trials