About this trial
This is a prospective, within-subject controlled study involving simultaneous dual placement of wireless Bravo pH probes in each participant. Patients will receive pH testing when symptomatic for gastroesophageal reflux disease (GERD) to confirm diagnosis as part of standard of care. Each test is 96 hours with a symptom diary, GERD-HRQL, and RSI collected, which is also standard of care for patients presenting with GERD symptoms.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults aged 18-90
Typical GERD symptoms (heartburn, regurgitation, chest discomfort)
No prior foregut surgery
Ability to undergo endoscopy with sedation and consent
Disqualifiers
Known motility disorders (e.g., achalasia)
Barrett's esophagus >3 cm
Pregnancy
Chronic opioid use
Trial design
Single group
Treatments tested in this trial
Bravo pH monitoring sessions
DeviceOne probe will be placed 1 cm above the SCJ (distal position), and the other 6 cm above the SCJ (standard position), using traditional SCJ visualization for placement. The capsule placed at the traditional 6 cm placement is standard of care for GERD diagnosis and will be billed through clinical care. The capsule placed at 1 cm above the SCJ is considered experimental and is the only one requiring study support. Thus only 80 additional capsules are requested through study support.
Treatment groups
Trial outcomes
Primary outcomes
Diagnostic sensitivity of Bravo pH testing defined by total percent time pH < 4 over the 96-hour monitoring period
One probe will be placed 1 cm above the SCJ (distal position), and the other 6 cm above the SCJ (standard position), using traditional SCJ visualization for placement to measure reflux episodes.
Secondary outcomes
Accuracy of EndoFLIP-derived LES localization compared to visually identified SCJ
EndoFLIP measurements will be collected independently to evaluate consistency or variation in LES localization and to analyze potential correlations with pH findings.
symptom diary
Patients will be asked to maintain their symptom diary for up to 14 days, with a minimum of 7 days required for inclusion in the study. Data will be collected according to standard Bravo protocol, including logging of mealtimes, symptom occurrence, and recumbency periods.
Comparison of concordance between DeMeester score at each probe location.
Standardized symptom assessment tools GERD-HRQL and RSI will be administered. Comparison of concordance between DeMeester score, total acid exposure time, and symptom burden (GERD-HRQL and RSI) at each probe location.
Comparison of concordance between total acid exposure time at each probe location.
Standardized symptom assessment tools GERD-HRQL and RSI will be administered. Comparison of concordance between DeMeester score, total acid exposure time, and symptom burden (GERD-HRQL and RSI) at each probe location.
Sponsors and contacts
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