Gastro Esophageal Reflux Disease Clinical Trial
Official title:
RD-41 Development of Applications of the Bravo® pH Monitoring System and Evaluation of Its Performance
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.
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
1. Evaluate physician subjective assessment questionnaire (appendix 3)
2. 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.
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