Quantitive And Qualitive Assessment Of The Oxygen Deliver... | NCT00814424

Studies
Quantitive And Qualitive Assessment Of The Oxygen Delivery And EtCO2 Sampling With The Smart Bite Block Mark III During An Upper Endoscopic Procedure Under Sedation

NCT00814424

Sponsor

Hadassah Medical Organization

Status

Unknown status

Last Update Posted

Dec 24, 2008Estimated

Enrollment

70Estimated

Phase

Not Applicable

Conditions

Ventilatory Status of Deeply Sedated ERCP Patients

Interventions

monitored using currently marketed smart biteblock o2
monitored using investigational smart biteblock

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

Status Module

Record Verification Date

Dec 2008

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2009

Primary Completion Date

May 2009Estimated

Completion Date

Jul 2009Estimated

First Submitted Date

Dec 23, 2008

First Submission Date that Met QC Criteria

Dec 23, 2008

First Posted Date

Dec 24, 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

Dec 23, 2008

Last Update Posted Date

Dec 24, 2008Estimated

Name	Class
Oridion	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

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 study hypothesis is that a modified smart bite block system can deliver up to 10 liters/minute of supplemental oxygen orally with the CO2 monitoring performance substantially equivalent to the currently marketed smart bite block that delivers oxygen up to 5 liters/minute

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

70Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Active Comparator	ERCP patients monitored using currently marketed smart biteblock o2	Device: monitored using currently marketed smart biteblock o2
2	Experimental	ERCP patients monitored using experimental biteblock delivering up to 10 lit/min oxygen	Device: monitored using investigational smart biteblock

Interventions

Name	Type	Description	Arm Group Labels	Other Names
monitored using currently marketed smart biteblock o2	Device	oral nasal CO2 monitoring and oxygen delivery	1

Measure	Description	Time Frame
EtCO2 measurement on the investigational device is equivalent to measurement on the control device		3 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

For the Adults Bite Bloc:Adults >18 years old and able to understand and give consent per the Ethics committee requirements,or younger patients requiring an Adult size Bite Bloc in the opinion of the PI for whom the legal guardians consented for the participation of the trial.
Patients consented or which their legal guardians consented for the participation of this trial.
Clinical need to use a Bite Bloc to maintain an open mouth and protect the endoscope.
Pediatric patients:patients with small mouth that the PI thinks require a Pediatric Bite Bloc (36 French),which their legal guardians consented for the participation of this trial.

Exclusion Criteria:

Patients who are pregnant.
Patients who in the opinion of the investigator should not participate.
For Pediatric Bite Bloc:patients who need an Adult Bite Bloc to the investigators opinion or above the age of 12.
Patients receiving oral or intravenous anticoagulants other than Aspirin or Plavix.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
DAVID GOZAL, M.D.	Contact	00 972 2 6777752		DAVIDGOZAL@YAHOO.COM
MURIEL COHEN, MSc	Contact	00 972 2 6777752		MURIEL@HADASSAH.ORG.IL

Overall Officials

Name	Affiliation	Role
DAVID GOZAL, M.D.	Hadassah Medical Organization	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hadassah Medical Organization		Jerusalem		91120	Israel

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

No data available

No data is available for this block.

Intervention Browse Module

No data available

No data is available for this block.