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Trial record 1 of 1 for:    Product Validation Study of 2 new devices, EZ-NG (RightSpot pH indicator) and EZ-pH (RightLevel pH Indicator)
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Product Validation Study of 2 New Devices, EZ-NG (RightSpot pH Indicator) and EZ-pH (RightLevel pH Indicator)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02065661
First Posted: February 19, 2014
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Florida Hospital Tampa Bay Division
  Purpose

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.

  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.
  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.

Condition
Small Bowel Obstruction Colectomy Bowel Surgeries

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Product Validation Study of 2 New Devices, EZ-NG (RightSpot pH Indicator) and EZ-pH (RightLevel pH Indicator)

Further study details as provided by Florida Hospital Tampa Bay Division:

Primary Outcome Measures:
  • 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. [ Time Frame: 60 min ]

Secondary Outcome Measures:
  • 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. [ Time Frame: 60 min ]

Enrollment: 30
Study Start Date: September 2011
Study Completion Date: February 2014
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Consented elective surgical candidates
Criteria

Inclusion Criteria:

  • Consented elective surgical patient

Exclusion Criteria:

  Contacts and Locations
No Contacts or Locations Provided
  More Information

Responsible Party: Florida Hospital Tampa Bay Division
ClinicalTrials.gov Identifier: NCT02065661     History of Changes
Other Study ID Numbers: EZ Product Validation Study
First Submitted: February 14, 2014
First Posted: February 19, 2014
Last Update Posted: October 12, 2017
Last Verified: February 2014

Additional relevant MeSH terms:
Intestinal Obstruction
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases