Ignite Creation Date:
2024-05-06 @ 2:18 AM
Last Modification Date:
2024-10-26 @ 11:16 AM
Study NCT ID:
NCT02010112
Status:
COMPLETED
Last Update Posted:
2022-12-20
First Post:
2013-12-05
Brief Title:
Bag Mode BreathID Hp Validation Versus Endoscopy in Detection of Helicobacter Pylori
Sponsor:
Meridian Bioscience Inc
Organization:
Meridian Bioscience Inc
Study Overview
Official Title:
Clinical Validation Study to Evaluate Presence of H Pylori With 13C-Urea Breath Test Using the Dual Mode BreathID Hp System Compared to Congruent Biopsy Results
Status:
COMPLETED
Status Verified Date:
2022-12
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:
A new method of breath collection for testing for Helicobacter Pylori infection has been developed by Exalenz In this study it will be compared to the gold standard- endoscopy results to prove its accuracy
Detailed Description:
This study will validate a breath collection method by comparing a newly developed breath test kit IDkitHp TWO using breath collection bags to congruent biopsy results a composite reference standard by analyzing specimens with microbial culture histological examination and rapid urease test- RUT in detecting HPylori
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None