Status:
COMPLETED
Development of Applications of the Bravo® pH Monitoring System and Evaluation of Its Performance
Lead Sponsor:
Medtronic - MITG
Conditions:
Gastro Esophageal Reflux Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 ...
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 patient...
Eligibility Criteria
Inclusion
- Subject age ≥ 18 years old
- Subject received an explanation about the nature of the study and agrees to provide written informed consent.
- Group A (healthy volunteers) Only
- Subject is an healthy volunteer
- Group B (symptomatic patients) Only 1. 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)
Exclusion
- Group A and B-
- 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
- Additional exclusion criteria for Group B only
- 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 -
Key Trial Info
Start Date :
February 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2016
Estimated Enrollment :
170 Patients enrolled
Trial Details
Trial ID
NCT01503476
Start Date
February 1 2012
End Date
March 1 2016
Last Update
July 31 2019
Active Locations (1)
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1
Bikur Holim medical center
Jerusalem, Israel