Small Bowel Obstruction Clinical Trial
Official title:
Product Validation Study of 2 New Devices, EZ-NG (RightSpot pH Indicator) and EZ-pH (RightLevel pH Indicator)
| Verified date | February 2014 |
| Source | Florida Hospital Tampa Bay Division |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 30 |
| Est. completion date | February 2014 |
| Est. primary completion date | June 2013 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | N/A and older |
| Eligibility |
Inclusion Criteria: - Consented elective surgical patient Exclusion Criteria: |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Florida Hospital Tampa Bay Division |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | 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 |
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