Development of Applications of the Bravo® pH Monitoring System and Evaluation of Its Performance (Encore)

Study Overview
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Brief Summary
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Study Hypothesis: This study is designed as an integral part of the development of new or improved features or components of the Bravo® pH Monitoring System and may serve verification and validation purposes. The study population will include symptomatic patients with known or suspected gastroesophageal reflux disease Symptomatic patients will undergo invasive procedure, including Bravo capsule delivery, positioning and attachment. Confirmation of capsule attachment may be done endoscopically. These procedures will serve to evaluate overall system performance in actual clinical setup, for instance: ergonomics and performance of delivery device, capsule transmission etc. Physician may be asked to provide feedback on the procedure and/or document their activities during the procedure.

Detailed Description
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The study population consists of symptomatic patients with known or suspected gastro esophageal reflux disease. The aim of this clinical study is to evaluate Bravo® pH Monitoring System. Primary objectives To evaluate usability and functionality of the Bravo® pH Monitoring System and procedure To evaluate modifications to the Bravo delivery device Primary Endpoints Evaluate physician subjective assessment questionnaire (appendix 3) Percentage of successful capsule attachments Patients will undergo standard-of-care Bravo pH procedure. Prior to the pH study, the patient should not eat or drink for a minimum of 6 hours, according to the standard system instructions. Bravo procedure may take 48-96 hours Patients will have a follow-up visit or call, one to two weeks after the procedure A fluoroscopy procedure may be ordered at physician's discretion to verify capsule attachment \ detachment from the patient's esophagus Over all expected duration for subject's participation in the study will be a maximum of 1 month Physician may be asked to provide feedback on the procedure usability and functionality and to document their activities during the procedure.

Official Title
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RD-41 Development of Applications of the Bravo® pH Monitoring System and Evaluation of Its Performance

Conditions
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Gastro Esophageal Reflux Disease

Intervention / Treatment
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* Device: Bravo pH monitoring procedure


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject age ≥ 18 years old Subject received an explanation about the nature of the study and agrees to provide written informed consent. The subject was referred for pH monitoring procedure to detect acid reflux for at least one of the following reasons: Burning substernal chest pain (heartburn) Regurgitation of food or stomach contents Dysphagia Epigastric pain Non-erosive reflux disease (NERD) Chest pain Cough Hoarseness Asthma Lower pharyngeal irritation, need to clear throat Exclusion Criteria: Subject has a cardiac pacemaker or other implanted electromedical device. Subject has any condition, which precludes compliance with study and/or device instructions. Women who are either pregnant or nursing at the time of screening, or are of child-bearing potential and do not practice medically acceptable methods of contraception. Subject suffers from life threatening conditions Subject currently participating in another clinical study which may interfere with study objectives, per physician discretion Subject has prior abdominal surgery other than uncomplicated procedures that would be unlikely to lead to bowel obstruction based on the clinical judgment of the investigator Subject is schedule to undergo MRI examination within 30 days from pH monitoring procedure. Subject has known bleeding diathesis, strictures, severe esophagitis, varices and or obstructions

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: pH monitoring procedure<br>Bravo pH monitoring procedure | Device: Bravo pH monitoring procedure<br>* Bravo pH monitoring procedure<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate physician subjective assessment questionnaire |  | post Bravo pH monitoring pinning procedure, same day of procedure | 
| Percentage of successful capsule attachments |  | post Bravo pH monitoring pinning procedure, same day of procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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GERD