Safety and Efficacy Study of the NG Shield, a Device Intended to Reduce Pain and Discomfort Level Related to Nasogasstric Tube Usage
Evaluation of Safety and Efficacy of the NasoGastric Shield (NG Shield) in Healthy Subjects With Indwelling Nasogastric Tube
1 other identifier
interventional
24
1 country
1
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 internal orifice (nose and pharynx)using micro vibrations
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Sep 2008
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2008
CompletedFirst Submitted
Initial submission to the registry
October 26, 2008
CompletedFirst Posted
Study publicly available on registry
October 28, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2008
CompletedMarch 25, 2009
March 1, 2009
2 months
October 26, 2008
March 24, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Pain/discomfort levelusing flicker scale (1-10 scale)during indwelling phase
every 30 minutes for 6 hours
safety of device usage
6 hours
Secondary Outcomes (1)
pain/Dicomfort during insertion and removal of the nasogastric tube
at t=0h and t=6h
Study Arms (2)
1
EXPERIMENTALstarting with active NG Shield
2
EXPERIMENTALStarting with inactive NG Shield
Interventions
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Nanovibronixlead
Study Sites (1)
"Bikur Cholim" Hospital
Jerusalem, Israel
Study Officials
- PRINCIPAL INVESTIGATOR
Shmuel Adler, M.D
"Bikur Cholim" Hospital, Jerusalem ISRAEL
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
October 26, 2008
First Posted
October 28, 2008
Study Start
September 1, 2008
Primary Completion
November 1, 2008
Study Completion
December 1, 2008
Last Updated
March 25, 2009
Record last verified: 2009-03