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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: GERD
• Intervention / Treatment: Device: Bravo pH monitoring sessions

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.

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yalini Vigneswaran; Phone Number: 773-702-6337; Email: yvigneswaran@bsd.uchicago.edu
• Study Contact Backup: Name: Guadalupe Castro; Phone Number: 773-834-6122; Email: Guadalupe.Castro@bsd.uchicago.edu

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60637
      • The University o Chicago
      • Contact: Yalini Vigneswaran; Phone Number: 773-702-6337; Email: yvigneswaran@bsd.uchicago.edu
      • Contact: Guadalupe Castro; Phone Number: 7738342531; Email: Guadalupe.Castro@bsd.uchicago.edu
      • Principal Investigator: Yalani Vigneswaran, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: one Bravo pH monitoring sessions; Each participant will undergo one Bravo pH monitoring sessions with two simultaneous probes placed Standard Bravo probe placed 6 cm above SCJ as standard of care. Experimental Bravo probe placed 1 cm above SCJ at the same time of standard of care procedure

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Days 0-Day 4

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Day 0
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.	Day 0- Day 14
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.	Day 5- Day 10
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.	Day 5- Day 10
Comparison of concordance between symptom burden (GERD-HRQL and RSI) 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.	Day 5- Day 10
Correlation of EndoFLIP metrics (LES distensibility, diameter) with DeMeester score and acid exposure	EndoFLIP measurements will be collected independently to evaluate consistency or variation in LES localization and to analyze potential correlations with pH findings.	Day 0

Collaborators and Investigators

• Sponsor: University of Chicago

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: July 16, 2026
• First Submitted That Met QC Criteria: July 16, 2026
• First Posted (Actual): July 21, 2026

Study Record Updates

• Last Update Posted (Actual): July 21, 2026
• Last Update Submitted That Met QC Criteria: July 16, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: symptomatic for GERD; Bravo pH probes i
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Esophageal Diseases; Esophageal Motility Disorders; Deglutition Disorders; Gastroesophageal Reflux
• Other Study ID Numbers: IRB25-1365

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes