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NCT04607304 · ClinicalTrials.gov registry record · NA
ABCA2 GIRMS Analytical Validation Clinical Performance Study
A NA study, sponsored by Cairn Diagnostics.
- Completed
- Registry status
- NA
- Development phase
- 95
- Enrollment target
NCT04607304: Completed NA study, sponsored by Cairn Diagnostics.
NCT04607304 is a NA study that has completed, run by Cairn Diagnostics. The registered enrollment target is 95 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04607304, a NA study, has completed, sponsored by Cairn Diagnostics.
- COMPLETED
- Registry status
- NA
- Development phase
- 95 participants
- Enrollment target
Study Summary
The purpose of this study is to collect human breath samples for use in a validation study intended to demonstrate equivalent clinical performance measures of new ABCA2 GIRMS (Automated Breath Carbon Analyzer-2 Gas Isotope Ratio Mass Spectrometer) instruments to the currently FDA-approved ABCA GIRMS (Automated Breath Carbon Analyzer Gas Isotope Ratio Mass Spectrometer) system. ABCA GIRMS systems are used to analyze the ratio of 13CO2 to 12CO2 in patient breath samples during the GEBT (Gastric Emptying Breath Test) procedure.
Primary Outcome
Gastric emptying rates (kPCD) values compared between the validated ABCA GIRMS system and the new ABCA2 GIRMS systems for each GEBT post meal collection timepoint (45, 90, 120, 150, 180 and 240-minute timepoints) and the overall diagnosis
Interventions
- DEVICE ABCA2 GIRMS
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 95 participants |
| Start Date | 2020-10-08 |
| Est. Completion | 2021-07-27 |
| Phase | NA |
What the finished NCT04607304 record still lists
NCT04607304 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 95 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (93% lower).
The record links to 0 conditions, and to 1 intervention - of which ABCA2 GIRMS is the first listed.
NCT04607304 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04607304 about?
NCT04607304 is a clinical study titled "ABCA2 GIRMS Analytical Validation Clinical Performance Study". The purpose of this study is to collect human breath samples for use in a validation study intended to demonstrate equivalent clinical performance measures of new ABCA2 GIRMS (Automated Breath Carbon Analyzer-2 Gas Isotope Ratio Mass Spectrometer) instruments to the currently FDA-approved ABCA GIRMS...
What is the current status of trial NCT04607304?
This trial is currently completed. It is a NA study. The enrollment target is 95 participants. The study started on 2020-10-08. Estimated completion is 2021-07-27.
What interventions are being tested in trial NCT04607304?
The interventions under investigation include: ABCA2 GIRMS (DEVICE).
Who is sponsoring clinical trial NCT04607304?
This trial is sponsored by Cairn Diagnostics, which has 5 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04607304's enrollment target sits among peer trials
95 931st of 2000 higher than 1,066 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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