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

ConditionGERD
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-90
SponsorUniversity of Chicago

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • Bravo pH monitoring sessions

    Device

    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.

Treatment groups

80 Participants
are divided into 1 treatment group
Group A: one Bravo pH monitoring sessionsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Days 0-Day 4

Secondary outcomes

1

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.

Time frame
Day 0
2

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.

Time frame
Day 0- Day 14
3

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.

Time frame
Day 5- Day 10
4

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.

Time frame
Day 5- Day 10

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: