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

Gastro Esophageal Reflux Disease Clinical Trial

Official title: RD-40 Development of Applications of the Bravo® pH Monitoring System and Evaluation of Its Performance

Status Completed

Clinical Trial Summary

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 a group of healthy volunteers (Group A) and a group of symptomatic patients with known or suspected gastroesophageal reflux disease (Group B).

Group A: Healthy volunteers will not undergo invasive procedure. These volunteers may be asked to carry the capsule and\or Bravo Recorder. These procedures will serve to evaluate different technical matters such as human interface, ergonomic aspects and communication performances of the system Group B: Symptomatic patients will undergo invasive procedure, including Bravo capsule delivery, positioning and attachment. Confirmation of capsule attachment may be done by endoscopically.

These procedures will serve to evaluate overall system performance in actual clinical setup, for instance: Bravo Recorder performance including communication quality, human interface and similar, ergonomics of delivery device, pH Capsule performance, etc.

Subjects from both study groups as well as physician may be asked to provide feedback on the procedure and/or document their activities during the procedure.

Clinical Trial Description

Up to a total of 220 subjects will participate in this study. The study will include two separate population groups. Group A of up to 170 healthy volunteers and Group B of up to 50 symptomatic patients with known or suspected gastro esophageal reflux disease. ;

Related Conditions & MeSH terms

• Esophagitis, Peptic
• Gastro Esophageal Reflux Disease
• Gastroesophageal Reflux

• NCT number: NCT01503476
• Study type: Interventional
• Source: Medtronic - MITG
• Status: Completed
• Phase: Phase 4
• Start date: February 2012
• Completion date: March 2016