N/A Completed N=39 Randomized Single-blind Diagnostic

Feasibility of Placing Bravo PH Capsule in Proximal Esophagus

Source: ClinicalTrials.gov NCT00378898 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Apr 2017

Primary outcomePrimary: Patients Requiring Endoscopic Removal of BRAVO Because of Reported Discomfort — 2; 0 participants

Summary

Assessing the feasibility and patient tolerance to placement of Bravo PH capsule in proximal esophagus. There will be no difference in patient-perception of a proximally-placed Bravo esophageal pH monitor compared with a distal monitor.

Outcome Measures

Outcome	Result	p-value
PRIMARY Patients Requiring Endoscopic Removal of BRAVO Because of Reported Discomfort	2; 0	—
SECONDARY Subjects Reporting Chest Pain	6; 3	.047 sig

Eligibility Criteria

Inclusion Criteria

Inclusion criteria will include the following:
Patients greater than or equal to 18 years of age
Patients having regularly scheduled upper endoscopy with planned Bravo pH monitor testing
Patients with known GERD based on symptoms (heartburn, regurgitation) and response to a proton pump inhibitor or esophagitis on EGD as well as those with extraesophageal GERD (cough, asthma and throat discomfort).

Exclusion Criteria

Exclusion criteria will include the following:
Previous surgical procedures to the upper esophagus
History of bleeding diathesis or coagulopathy
Stroke or transient ischemic attack within the past 6 months
GI bleeding within the previous 6 months
Known esophageal varices
Significant medical illness (i.e., congestive heart failure)
Pregnancy

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Data sourced from ClinicalTrials.gov (NCT00378898). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.