PROPER-GERD: A Prospective Crossover Study to Evaluate Probe Placement Optimization for Reflux Testing in Women and Lower-BMI Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Bravo pH monitoring sessions.
- Who it may be relevant to
- Registry conditions: GERD. Basic parameters: 18 years — 90 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Detailed 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 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.
Interventions
- Device Bravo 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.
Primary outcome measures
- Diagnostic sensitivity of Bravo pH testing defined by total percent time pH < 4 over the 96-hour monitoring period [Time frame: Days 0-Day 4]
Secondary outcome measures (6)
- Accuracy of EndoFLIP-derived LES localization compared to visually identified SCJ [Time frame: Day 0]
- symptom diary [Time frame: Day 0- Day 14]
- Comparison of concordance between DeMeester score at each probe location. [Time frame: Day 5- Day 10]
- Comparison of concordance between total acid exposure time at each probe location. [Time frame: Day 5- Day 10]
- Comparison of concordance between symptom burden (GERD-HRQL and RSI) at each probe location. [Time frame: Day 5- Day 10]
- Correlation of EndoFLIP metrics (LES distensibility, diameter) with DeMeester score and acid exposure [Time frame: Day 0]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
United States · 1 center
- The University o Chicago — Chicago
Identifiers
NCT: NCT07716592 · IRB25-1365