Gastro Esophageal Reflux DiseasePhase 4NCT01503476
Development of Applications of the Bravo® pH Monitoring System and Evaluation of Its Performance
A Phase 4 study testing Bravo® pH Monitoring System in people with Gastro Esophageal Reflux Disease, run by Medtronic - MITG at 1 site in Israel.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gastro Esophageal Reflux Disease
- What is being tested?
- Bravo® pH Monitoring System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 1 siteIsrael
- Study dates
- Feb 2012to Mar 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
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- Regurgitation of food or stomach contents
- Dysphagia
- Epigastric pain
- Non-erosive reflux disease (NERD)
Who cannot join
- 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
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- 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 -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: RD-40 Development of Applications of the Bravo® pH Monitoring System and Evaluation of Its Performance
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).
Read more
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.
Read the 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
- Being tested
- Bravo® pH Monitoring System
- Keywords
- gastro esophageal reflux disease
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bravo® pH Monitoring SystemDevice
Also called pH monitoring
Bravo pH monitoring
Bravo® pH Monitoring SystemDevice
Also called pH monitoring
Bravo pH monitoring
| Study group | Role | What they receive |
|---|---|---|
| Healthy volunteers | Experimental | healthy volunteers Receives: Device: Bravo® pH Monitoring System |
| symptomatic patients | Experimental | symptomatic patients with known or suspected gastro esophageal reflux disease Receives: Device: Bravo® pH Monitoring System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: up to 96 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2012 (estimated)
- Study startFeb 2012
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastro Esophageal Reflux DiseaseStudies of the same condition, open and under way.
- More trials run by Medtronic - MITGThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic - MITG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Samuel Adler, M.D., Principal investigator, Bikur Holim medical center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01503476
- Sponsor's protocol ID
- RD-40
- Status last verified
- Jul 2015
- First submitted
- 25 Dec 2011
- Last updated
- 31 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RD-40 Development of Applications of the Bravo® pH Monitoring System and Evaluation of Its Performance
- ClinicalTrials.gov ID
- NCT01503476
- Acronym / sponsor ID
- RD-40
- Conditions
- Gastro Esophageal Reflux Disease
- Keywords
- gastro esophageal reflux disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 170 participants (actual)
- Lead sponsor
- Medtronic - MITGIndustry (pharma, biotech, devices)
- Study start
- Feb 2012
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 4 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy volunteers | Experimental | Device: Bravo® pH Monitoring Systemhealthy volunteers |
| symptomatic patients | Experimental | Device: Bravo® pH Monitoring Systemsymptomatic patients with known or suspected gastro esophageal reflux disease |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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:
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bravo® pH Monitoring SystemAlso: pH monitoringBravo pH monitoring | Device | symptomatic patients |
| Bravo® pH Monitoring SystemAlso: pH monitoringBravo pH monitoring | Device | Healthy volunteers |
Primary outcome
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)
Time frame: 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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Samuel Adler, M.D. principal investigator
Bikur Holim medical center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Bravo® pH Monitoring System in people with Gastro Esophageal Reflux Disease, run by Medtronic - MITG at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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) (time frame: up to 96 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2019.