Product Validation Study of 2 New Devices, EZ-NG (RightSp... | NCT02065661

Studies
Product Validation Study of 2 New Devices, EZ-NG (RightSpot pH Indicator) and EZ-pH (RightLevel pH Indicator)

NCT02065661

Sponsor

Florida Hospital Tampa Bay Division

Status

Completed

Last Update Posted

Feb 19, 2014Estimated

Enrollment

30Actual

Phase

Not provided

Conditions

Small Bowel Obstruction
Colectomy
Bowel Surgeries

Interventions

Not provided

Countries

Not provided

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

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2014

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 2011

Primary Completion Date

Jun 2013Actual

Completion Date

Feb 2014Actual

First Submitted Date

Feb 14, 2014

First Submission Date that Met QC Criteria

Feb 14, 2014

First Posted Date

Feb 19, 2014Estimated

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

Feb 14, 2014

Last Update Posted Date

Feb 19, 2014Estimated

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

EZ Holdco Inc. has developed two devices for the measurement of gastric content pH. The devices, EZ-NG and EZ-pH, rapidly check gastric pH by aspirating gastric contents into the device through a nasogastric (NG) tube and causing a color change in the device. The color change is then compared to the reference indicator on the device to determine a pH value of the aspirate. Currently there is no bedside rapid way to check gastric pH that protects the clinician from being exposed to the aspirate.

Primary Objective To assess the accuracy of the pH measurement of gastric fluid on the devices by comparing the reading on the 2 devices to a standard clinically approved pH probe.
Secondary Objective To determine what percentage of time the EZ-NG - RightSpot pH indicator could have been used to determine proper placement of the NG tube when initially placed.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
1. Primary Objective To assess the accuracy of the pH measurement of gastric fluid on the devices by comparing the reading on the 2 devices to a standard clinically approved pH probe.		60 min

Secondary Outcomes

Measure	Description	Time Frame
2. Secondary Objective To determine what percentage of time the EZ-NG - RightSpot pH indicator could have been used to determine proper placement of the NG tube when initially placed.		60 min

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Consented elective surgical patient

Exclusion Criteria:

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

Consented elective surgical candidates

Sampling Method

Non-Probability Sample

Type	Date	Date Unknown
Release	Jul 31, 2017
Reset	Jan 30, 2018
Release	Feb 7, 2018
Reset	Oct 29, 2018

Submission Tracking

Estimated Results First Submitted Date

Jul 31, 2017

First MCP Posted Date

Not provided

Submission Infos

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Jul 31, 2017			Jan 30, 2018
Feb 7, 2018