Back to resultsDevelopment of Applications of the Bravo® pH Monitoring System and Evaluation of Its Performance
Primary Purpose
Gastro Esophageal Reflux Disease
Status
Completed
Phase
Phase 4
Locations
Israel
Study Type
Interventional
Intervention
Bravo® pH Monitoring System
Bravo® pH Monitoring System
Sponsored by
About this trial
This is an interventional diagnostic trial for Gastro Esophageal Reflux Disease focused on measuring gastro esophageal reflux disease
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
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 -
Sites / Locations
- Bikur Holim medical center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Healthy volunteers
symptomatic patients
Arm Description
healthy volunteers
symptomatic patients with known or suspected gastro esophageal reflux disease
Outcomes
Primary Outcome Measures
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)
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)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01503476
Brief Title
Development of Applications of the Bravo® pH Monitoring System and Evaluation of Its Performance
Official Title
RD-40 Development of Applications of the Bravo® pH Monitoring System and Evaluation of Its Performance
Study Type
Interventional
2. Study Status
Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
February 2012 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
March 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medtronic - MITG
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastro Esophageal Reflux Disease
Keywords
gastro esophageal reflux disease
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
170 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Healthy volunteers
Arm Type
Experimental
Arm Description
healthy volunteers
Arm Title
symptomatic patients
Arm Type
Experimental
Arm Description
symptomatic patients with known or suspected gastro esophageal reflux disease
Intervention Type
Device
Intervention Name(s)
Bravo® pH Monitoring System
Other Intervention Name(s)
pH monitoring
Intervention Description
Bravo pH monitoring
Intervention Type
Device
Intervention Name(s)
Bravo® pH Monitoring System
Other Intervention Name(s)
pH monitoring
Intervention Description
Bravo pH monitoring
Primary Outcome Measure Information:
Title
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)
Description
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)
Time Frame
up to 96 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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 -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Samuel Adler, M.D.
Organizational Affiliation
Bikur Holim medical center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bikur Holim medical center
City
Jerusalem
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
Development of Applications of the Bravo® pH Monitoring System and Evaluation of Its Performance
We'll reach out to this number within 24 hrs