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

Part of paid clinical trials in Chicago, Illinois.

Sponsor
University of Chicago
Study ID
NCT07716592
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

  • GERD

Eligibility Criteria

Sex
ALL
Age
18 Years - 90 Years
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

First listed
Jul 21, 2026
Start date
Aug 31, 2026
Status verified
Jul 2026
Primary completion
Dec 31, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
80 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • 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

Primary Outcome Measure

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 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The University o ChicagoChicagoIllinois60637
Yalini Vigneswaran
[email protected]
773-702-6337
Guadalupe Castro
[email protected]
7738342531
Yalani Vigneswaran, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Chicago, IL

By research site
The University o Chicago· Chicago, IL

Related Studies