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NCT01650831 · ClinicalTrials.gov registry record · NA
Show Equivalence of the Modified BreathID Compared to Currently Approved BreathID in H.Pylori Detection
A NA study of Suspicion of Being Infected With H.Pylori, sponsored by Meridian Bioscience.
- Completed
- Registry status
- NA
- Development phase
- 113
- Enrollment target
- 1
- Study location
NCT01650831: Completed NA study of Suspicion of Being Infected With H.Pylori, sponsored by Meridian Bioscience.
NCT01650831 is a NA study of Suspicion of Being Infected With H.Pylori that has completed, run by Meridian Bioscience. The registered enrollment target is 113 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (92% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01650831, a NA study of Suspicion of Being Infected With H.Pylori, has completed, sponsored by Meridian Bioscience.
- COMPLETED
- Registry status
- NA
- Development phase
- 113 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to confirm equivalence of a new generation breath analyzer (Modified BreathID) in its ability to detect H. pylori compared to the currently approved BreathID® System.
Primary Outcome
The marketed (cleared) BreathID device and the investigational modified new generation BreathID device will measure simultaneously before (baseline) and after ingestion of substrate. The subject will be connected to both devices. The maximum time of measurement is 25 minutes.
Conditions Studied
Interventions
- DEVICE Modified BreathID
Study Locations (1)
New Jersey
- Unimed Center - East Brunswick
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 113 participants |
| Start Date | 2012-10 |
| Est. Completion | 2013-01 |
| Phase | NA |
What the finished NCT01650831 record still lists
NCT01650831 is an interventional study that assigns participants to a tested intervention. The registered 113 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (92% lower).
The record links to 1 condition, with Suspicion of Being Infected With H.Pylori appearing as the primary indexed condition, and to 1 intervention - of which Modified BreathID is the first listed.
NCT01650831 reports a single indexed study location in New Jersey.
Frequently Asked Questions
What is clinical trial NCT01650831 about?
NCT01650831 is a clinical study titled "Show Equivalence of the Modified BreathID Compared to Currently Approved BreathID in H.Pylori Detection". The purpose of this study is to confirm equivalence of a new generation breath analyzer (Modified BreathID) in its ability to detect H. pylori compared to the currently approved BreathID® System.
What is the current status of trial NCT01650831?
This trial is currently completed. It is a NA study. The enrollment target is 113 participants. The study started on 2012-10. Estimated completion is 2013-01.
What conditions does trial NCT01650831 study?
This clinical trial studies the following conditions: Suspicion of Being Infected With H.Pylori.
What interventions are being tested in trial NCT01650831?
The interventions under investigation include: Modified BreathID (DEVICE).
Who is sponsoring clinical trial NCT01650831?
This trial is sponsored by Meridian Bioscience, which has 19 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01650831 being conducted?
This trial has 1 study location across New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01650831's enrollment target sits among peer trials
113 813th of 2000 higher than 1,188 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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