NCT01503476

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 170 (actual)
• Sponsor: Medtronic - MITG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Gastro Esophageal Reflux Disease

Interventions

Type	Name	Description
DEVICE	Bravo® pH Monitoring System	Bravo pH monitoring
DEVICE	Bravo® pH Monitoring System	Bravo pH monitoring

Timeline

• Start date: 2012-02-01
• Primary completion: 2016-03-01
• Completion: 2016-03-01
• First posted: 2012-01-04
• Last updated: 2019-07-31

Locations

1 site across 1 country: Israel