Ignite Creation Date:
2024-05-06 @ 7:25 AM
Last Modification Date:
2024-10-26 @ 11:48 AM
Study NCT ID:
NCT02528721
Status:
COMPLETED
Last Update Posted:
2022-12-20
First Post:
2015-08-17
Brief Title:
Exalenz Lab Mode System Compared to Biopsy for HPylori Detection
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 BreathID Hp Lab System Compared to 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:
The Exalenz Dual Mode BreathID Hp System comprised of IDkit Hp TWO and the Dual Mode BreathID Hp test device will be used to perform a urea breath test in the initial diagnosis and post treatment monitoring of Hpylori infection in adult patients and its results will be compared to biopsy results
Detailed Description:
Patients undergoing esophagogastroduodenoscopy EGD for initial diagnosis of Hpylori infection or post therapy confirmation of eradication will be eligible to participate in the trial Two sets of biopsies will be taken one set for histological analysis and one set for rapid urease test RUT analysis The two results will be used as a gold standard composite score in determining the presence of Hpylori bacteria in the stomach The Urea Breath Test UBT using the Exalenz Dual Mode BreathID Hp System will also be performed within a week of the biopsy The outcome of the UBT will be compared to composite score of the biopsy and the accuracy of the UBT will be evaluated The UBT will be performed using breath collection bags where the subject will be asked to breathe into the bags before and after ingestion of the 13C-labelled urea
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