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NG Shield

Phase 2

Intubation, Nasogastric | Unknown | Gastrointestinal |NanoVibronix, Inc.|Last Updated: Mar 25, 2009

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindCONTROLLEDDMC
Total Trials1
Total Enrollment24
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00781248Safety and Efficacy Study of the NG Shield, a Device Intended to Reduce Pain and Discomfort Level Related to Nasogasstric Tube UsagePHASE2 COMPLETED 24 — — Sep 1, 2008Dec 1, 2008Mar 25, 20091 Israel
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Study Endpoints
Primary Endpoints
Pain/discomfort levelusing flicker scale (1-10 scale)during indwelling phase
every 30 minutes for 6 hours
safety of device usage
6 hours
Secondary Endpoints
pain/Dicomfort during insertion and removal of the nasogastric tube
at t=0h and t=6h
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER
PurposeSUPPORTIVE_CARE
Treatment Arms
ArmTypeDescription
1EXPERIMENTALstarting with active NG Shield
2EXPERIMENTALStarting with inactive NG Shield
Interventions
NameTypeDescription
NG ShieldDEVICEA device to reduce pain/discomfort related to nasogastric tube usage
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Subject is in good health and able to undergoes the NG tube insertion procedure, according to the PI decision 2. Subject is able to understand and answer the pain and discomfort questionnaires 3. Subject has been fasting for at least 12h prior to the insertion phase 4. Subjec...

Countries:Israel
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