Bravo pH Monitoring for Acid Reflux

(PROPER-GERD Trial)

YV
GC
Overseen ByGuadalupe Castro
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Chicago
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the effectiveness of a special pH monitoring device for diagnosing gastroesophageal reflux disease (GERD), which causes symptoms like heartburn and chest discomfort. Researchers will use the Bravo pH monitoring system, inserting two small probes to measure acid levels in the esophagus when symptoms occur. Participants will also maintain a diary of their symptoms for four days. This trial suits adults who experience typical GERD symptoms and have not undergone previous stomach or esophagus surgeries. As an unphased trial, it offers participants the chance to contribute to valuable research that could enhance GERD diagnosis.

What prior data suggests that the Bravo pH monitoring is safe for GERD patients?

Research has shown that the Bravo pH Monitoring System is very safe. Studies have found it to be a reliable method for checking acid levels in the esophagus. Most people find it easy to use and tolerate well. Some might experience a slight sensation in the chest or discomfort when swallowing, but these effects are usually mild. Overall, the Bravo system offers a more comfortable option compared to older tube-based methods, making it a good choice for confirming gastroesophageal reflux disease (GERD).12345

Why are researchers excited about this trial?

Researchers are excited about the Bravo pH monitoring sessions for acid reflux because they offer a unique way to measure acid levels in the esophagus. Unlike traditional methods that typically involve a single probe placed higher in the esophagus, this new approach uses two probes, with one positioned just 1 cm above the stomach junction. This closer placement allows for more precise monitoring of acid exposure, which could lead to more accurate diagnoses and better tailored treatments for individuals with acid reflux. By improving the precision of acid measurements, this technique has the potential to enhance the understanding of acid reflux patterns and improve patient outcomes.

What evidence suggests that Bravo pH monitoring is effective for GERD?

Research has shown that Bravo pH monitoring effectively diagnoses gastroesophageal reflux disease (GERD) by measuring acid levels in the esophagus. Studies indicate it can track data for 48 to 96 hours, surpassing traditional methods. This extended monitoring period helps accurately identify acid reflux patterns, improving the chances of detecting GERD symptoms and leading to a more reliable diagnosis. In this trial, participants will undergo one Bravo pH monitoring session with two simultaneous probes, including an experimental probe placement. The test is minimally invasive, making it easier for patients to handle. Overall, it serves as a valuable tool for confirming GERD and assessing its severity.14678

Are You a Good Fit for This Trial?

This trial is for women and people with lower body weight who have symptoms of acid reflux (GERD) and need pH testing to confirm their diagnosis. Participants must be able to undergo standard reflux testing procedures.

Inclusion Criteria

I have common GERD symptoms like heartburn or regurgitation.
I have never had surgery on my esophagus, stomach, or upper small intestine.
I am between 18 and 90 years old.
See 1 more

Exclusion Criteria

I have a large type III or IV paraesophageal hernia.
I have had surgery on my esophagus or stomach, including hiatal hernia repair.
Chronic opioid use
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo Bravo pH monitoring with dual probe placement for 96 hours to evaluate reflux episodes

4 days
1 visit (in-person)

Symptom Diary Maintenance

Participants maintain a symptom diary for up to 14 days, with a minimum of 7 days required

7-14 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Bravo pH monitoring sessions

Trial Overview

The study tests two different placements of a wireless Bravo pH probe in the same person during a single test, aiming to find the best way to measure acid reflux. Each participant will wear both probes for about four days while tracking symptoms.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: one Bravo pH monitoring sessionsExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Chicago

Lead Sponsor

Trials
1,086
Recruited
844,000+

Citations

Evaluation of Gastroesophageal Reflux Disease Using ... - PMC

Compared with traditional 24-hour catheter-based pH monitoring, the Bravo pH data can be recorded for 48 hours or more. Esophageal acid exposures for the ...

Wireless Esophageal pH Test (Bravo Test)

Wireless pH testing is a minimally invasive test to help diagnose and assess symptoms of gastroesophageal reflux disease (GERD) and effectiveness of GERD ...

48 and 96 Hour Bravo Wireless Capsule pH Monitoring

The Bravo pH test plays an essential role in diagnosing acid reflux and GERD by measuring the frequency and severity of acid exposure in the esophagus. This ...

Bravo Esophageal pH Test: Capsule, Procedure & Results

A Bravo pH test measures the acidity of your esophagus, usually over two days. It helps diagnose and monitor GERD.

Bravo™ pH Monitoring Test - UC Health

Learn how the Bravo pH Monitoring Test helps diagnose acid reflux and GERD. Discover what to expect before, during and after this wireless ...

A Catheter-free pH Monitoring System for Evaluation of ... - PMC

The Bravo™ pH Monitoring System is a safe, reliable, and effective diagnostic tool with good tolerance for pediatric patients suspected of suffering from GERD.

Evaluation of Gastroesophageal Reflux Disease Using the ...

The Bravo pH monitoring system is a safe and well-tolerated alternative to the catheter-based pH monitoring. It is patient-friendly with the ability for ...

Bravo PH - Atrium Health Navicent Gastroenterology

Bravo pH helps the doctor to see the rate at which acid flows back up into the esophagus. Physicians use Bravo pH to see whether a patient is suffering from ...