Ignite Creation Date:
2024-05-06 @ 9:08 AM
Last Modification Date:
2024-10-26 @ 12:10 PM
Study NCT ID:
NCT02905825
Status:
COMPLETED
Last Update Posted:
2022-12-20
First Post:
2016-09-06
Brief Title:
Urea Breath Test UBT With Breath Hp System BreathID Hp Lab System Pediatrics
Sponsor:
Meridian Bioscience Inc
Organization:
Meridian Bioscience Inc
Study Overview
Official Title:
Clinical Confirmation Study to Confirm Safety and Presence of H Pylori With 13C-Urea Breath Test Using the BreathID Hp and BreathID Hp Lab Systems in the Pediatric Population
Status:
COMPLETED
Status Verified Date:
2018-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Clinical Study to Confirm Safety and Accuracy in Detection of H pylori with 13C-Urea Breath Test using the BreathID Hp and BreathID Hp Lab Systems in the Pediatric Population
Detailed Description:
Pediatric subjects with indication for Hpylori testing will be tested with both stool antigen as a reference standard and a urea breath test using the BreathID Hp and BreathID Hp Lab Systems The BreathID Hp system continuously measures breath via a nasal cannula and the BreathID Hp Lab System measures breath collection bags before and after ingestion of a solution with enriched carbon 13 urea and citric acid The stool sample will be provided within a week of the breath tests and will be analyzed by a central laboratory Safety and overall efficacy will be assessed
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None