PROPER-GERD: A Prospective Crossover Study to Evaluate Probe Placement Optimization for Reflux Testing in Women and Lower-BMI Patients
University of Chicago
Summary
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.
Description
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 p…
Eligibility
- Age range
- 18–90 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Adults aged 18-90 * Typical GERD symptoms (heartburn, regurgitation, chest discomfort) * No prior foregut surgery * Ability to undergo endoscopy with sedation and consent Exclusion Criteria: * Known motility disorders (e.g., achalasia) * Barrett's esophagus \>3 cm * Pregnancy * Chronic opioid use * Inability to tolerate endoscopy or EndoFLIP * Presence of large type III or IV paraesophageal hernia * Previous esophageal or gastric surgery, including previous hiatal hernia repair
Interventions
- DeviceBravo pH monitoring sessions
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.
Location
- The University o ChicagoChicago, Illinois