Gastro Esophageal Reflux Disease
Conditions
Keywords
gastro esophageal reflux disease
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 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.
Interventions
DEVICEBravo® pH Monitoring System
Bravo pH monitoring
Sponsors
Medtronic - MITG
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Subject age ≥ 18 years old 2. Subject received an explanation about the nature of the study and agrees to provide written informed consent. Group A (healthy volunteers) Only 3. 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 criteria
Group A and B- 1. Subject has a cardiac pacemaker or other implanted electromedical device. 2. Subject has any condition, which precludes compliance with study and/or device instructions. 3. 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. 4. Subject suffers from life threatening conditions 5. Subject currently participating in another clinical study which may interfere with study objectives, per physician discretion Additional
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of data samples transmitted by the capsule and successfully received by the receiver (e.g. percent of missed samples and percent of corrupted samples) | up to 96 hours | Percentage of data samples in healthy volunteers and patients transmitted by capsule and successfully received by the receiver (e.g. percent of missed samples and percent of corrupted samples) |
Countries
Israel
Outcome results
None listed