PROPER-GERD: A Prospective Crossover Study to Evaluate Probe Placement Optimization for Reflux Testing in Women and Lower-BMI Patients

GERD

symptomatic for GERD, Bravo pH probes i

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.

Each participant will undergo one Bravo pH monitoring sessions with two simultaneous probes placed Standard Bravo probe placed 6 cm above squamocolumnar junction (SCJ) as standard of care. Experimental Bravo probe placed 1 cm above SCJ at the same time of standard of care procedure 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. 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. EndoFLIP measurements will be collected independently to evaluate consistency or variation in LES localization and to analyze potential correlations with pH findings. These measurements will be reviewed in real-time, and if significant variation from SCJ-based localization is observed in the first 20 patients, the protocol may be amended to allow EndoFLIP-guided probe placement for the remaining participants. Significant variation will be defined as a mean discrepancy of greater than 2 cm between the SCJ-based and EndoFLIP-derived LES landmarks in greater than equal to 50 percent of the first 20 patients. If this threshold is met, the protocol will be amended to incorporate EndoFLIP-guided placement for subsequent participants. If no significant variation is found, we will continue collect EndoFLIP data in all participants as part of the research protocol. The primary use is to record the physiologic LES location and its distensibility, and to explore its potential value as an adjunctive diagnostic marker. Participants will undergo 96 hours of Bravo pH monitoring monitoring off acid suppression. 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. Standardized symptom assessment tools GERD-HRQL and RSI will be administered. This design allows for direct, matched comparisons of diagnostic yield between placement strategies within the same patient. Data management will be conducted using PatientIQ, the HIPAA-compliant institutional platform currently used at our site to collect clinical and research data. This includes both clinical variables and patient-reported outcomes.

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