Safety and Efficacy Study of the NG Shield, a Device Inte... | NCT00781248

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

NCT00781248

Sponsor

Nanovibronix

Status

Completed

Last Update Posted

Mar 25, 2009Estimated

Enrollment

24Estimated

Phase

Phase 2

Conditions

Intubation, Nasogastric

Interventions

NG Shield

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2008

Primary Completion Date

Nov 2008Actual

Completion Date

Dec 2008Actual

First Submitted Date

Oct 26, 2008

First Submission Date that Met QC Criteria

Oct 27, 2008

First Posted Date

Oct 28, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 24, 2009

Last Update Posted Date

Mar 25, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

24Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	starting with active NG Shield	Device: NG Shield
2	Experimental	Starting with inactive NG Shield	Device: NG Shield

Interventions

Name	Type	Description	Arm Group Labels	Other Names
NG Shield	Device	A device to reduce pain/discomfort related to nasogastric tube usage	1 2

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
pain/Dicomfort during insertion and removal of the nasogastric tube		at t=0h and t=6h

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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
Subject is currently participating in another clinical study

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided