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

NCT07716592 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: IRB25-1365
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

GERD

Keywords

symptomatic for GERD; Bravo pH probes i

Outcome Measures

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.

  Days 0-Day 4

Secondary Outcomes (6)

• Accuracy of EndoFLIP-derived LES localization compared to visually identified SCJ

  Day 0

• symptom diary

  Day 0- Day 14

• Comparison of concordance between DeMeester score at each probe location.

  Day 5- Day 10

• Comparison of concordance between total acid exposure time at each probe location.

  Day 5- Day 10

• Comparison of concordance between symptom burden (GERD-HRQL and RSI) at each probe location.

  Day 5- Day 10

Study Arms (1)

one Bravo pH monitoring sessions

EXPERIMENTAL

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

Interventions

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.

one Bravo pH monitoring sessions

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 18-90
• Typical GERD symptoms (heartburn, regurgitation, chest discomfort)
• No prior foregut surgery
• Ability to undergo endoscopy with sedation and consent

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Chicago: lead

Study Sites (1)

The University o Chicago

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Conditions

Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Central Study Contacts

Yalini Vigneswaran

CONTACT

773-702-6337; yvigneswaran@bsd.uchicago.edu

Guadalupe Castro

CONTACT

773-834-6122; Guadalupe.Castro@bsd.uchicago.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2026
• First Posted: July 21, 2026
• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: July 21, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)