ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    Product Validation Study of 2 new devices, EZ-NG (RightSpot pH indicator) and EZ-pH (RightLevel pH Indicator)
Previous Study | Return to List | Next Study

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

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.
ClinicalTrials.gov Identifier: NCT02065661
Recruitment Status : Completed
First Posted : February 19, 2014
Last Update Posted : February 19, 2014
Sponsor:
Information provided by (Responsible Party):
Florida Hospital Tampa Bay Division

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.

  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 or disease
Small Bowel Obstruction Colectomy Bowel Surgeries

Study Type : Observational
Actual Enrollment : 30 participants
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)
Study Start Date : September 2011
Actual Primary Completion Date : June 2013
Actual Study Completion Date : February 2014



Primary Outcome Measures :
  1. 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 :
  1. 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 ]


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:


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

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