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Sponsored by: |
Nanovibronix |
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Information provided by: | Nanovibronix |
ClinicalTrials.gov Identifier: | NCT00781248 |
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 |
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Intubation, Nasogastric |
Device: NG Shield |
Phase II |
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 |
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 |
---|---|
1: Experimental
starting with active NG Shield
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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
|
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | NanoVibronix ( Dr. Dagan Harris VP Clinical Affairs ) |
Study ID Numbers: | NV-NGS-06-001 |
Study First Received: | October 26, 2008 |
Last Updated: | March 24, 2009 |
ClinicalTrials.gov Identifier: | NCT00781248 History of Changes |
Health Authority: | Israel: Ministry of Health |
enteral feeding Subject who requires nasogastric tube |
Pain Healthy |