Gastro Esophageal Reflux DiseaseNCT01788085
Development of Applications of the Bravo® pH Monitoring System and Evaluation of Its Performance (Encore)
A study testing Bravo pH monitoring procedure 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastro Esophageal Reflux Disease
- What is being tested?
- Bravo pH monitoring procedure
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteIsrael
- Study dates
- Aug 2013to Mar 2014
- Phase
- Interventional
- 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
- No healthy volunteers
- 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.
- 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
Show all 13Show fewer
- Epigastric pain
- Non-erosive reflux disease (NERD)
- Chest pain
- Cough
- Hoarseness
- Asthma
- Lower pharyngeal irritation, need to clear throat
Who cannot join
- 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
- 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-41 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 symptomatic patients with known or suspected gastroesophageal reflux disease
Read more
Symptomatic patients will undergo invasive procedure, including Bravo capsule delivery, positioning and attachment. Confirmation of capsule attachment may be done endoscopically.
These procedures will serve to evaluate overall system performance in actual clinical setup, for instance: ergonomics and performance of delivery device, capsule transmission etc.
Physician may be asked to provide feedback on the procedure and/or document their activities during the procedure.
Read the detailed description
The study population consists of symptomatic patients with known or suspected gastro esophageal reflux disease. The aim of this clinical study is to evaluate Bravo® pH Monitoring System.
Primary objectives
- To evaluate usability and functionality of the Bravo® pH Monitoring System and procedure
- To evaluate modifications to the Bravo delivery device Primary Endpoints
- Evaluate physician subjective assessment questionnaire (appendix 3)
- Percentage of successful capsule attachments Patients will undergo standard-of-care Bravo pH procedure. Prior to the pH study, the patient should not eat or drink for a minimum of 6 hours, according to the standard system instructions.
- Bravo procedure may take 48-96 hours
- Patients will have a follow-up visit or call, one to two weeks after the procedure
- A fluoroscopy procedure may be ordered at physician's discretion to verify capsule attachment \ detachment from the patient's esophagus
Over all expected duration for subject's participation in the study will be a maximum of 1 month
Physician may be asked to provide feedback on the procedure usability and functionality and to document their activities during the procedure.
- Conditions
- Gastro Esophageal Reflux Disease
- Being tested
- Bravo pH monitoring procedure
- Keywords
- GERD
- 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 procedureDevice
Bravo pH monitoring procedure
| Study group | Role | What they receive |
|---|---|---|
| pH monitoring procedure | Experimental | Bravo pH monitoring procedure Receives: Device: Bravo pH monitoring procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate physician subjective assessment questionnaire
Measured: post Bravo pH monitoring pinning procedure, same day of procedure
Percentage of successful capsule attachments
Measured: post Bravo pH monitoring pinning procedure, same day of procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2013 (estimated)
- Study startAug 2013
- Primary completionMar 2014 (estimated)
- Study completionMar 2014 (estimated)
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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic - MITG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alexandra Lavy, Prof., Principal investigator, Bnei Zion MC, HAifa, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01788085
- Sponsor's protocol ID
- RD-41
- Status last verified
- Jul 2019
- First submitted
- 5 Feb 2013
- 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-41 Development of Applications of the Bravo® pH Monitoring System and Evaluation of Its Performance
- ClinicalTrials.gov ID
- NCT01788085
- Acronym / sponsor ID
- RD-41
- Conditions
- Gastro Esophageal Reflux Disease
- Keywords
- GERD
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Medtronic - MITGIndustry (pharma, biotech, devices)
- Study start
- Aug 2013
- Primary completion
- Mar 2014 (estimated)
- Study completion
- Mar 2014 (estimated)
- First posted
- 11 Feb 2013 (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 symptomatic patients with known or suspected gastroesophageal reflux disease
Symptomatic patients will undergo invasive procedure, including Bravo capsule delivery, positioning and attachment. Confirmation of capsule attachment may be done endoscopically.
These procedures will serve to evaluate overall system performance in actual clinical setup, for instance: ergonomics and performance of delivery device, capsule transmission etc.
Physician may be asked to provide feedback on the procedure and/or document their activities during the procedure.
Detailed description
The study population consists of symptomatic patients with known or suspected gastro esophageal reflux disease. The aim of this clinical study is to evaluate Bravo® pH Monitoring System.
Primary objectives
- To evaluate usability and functionality of the Bravo® pH Monitoring System and procedure
- To evaluate modifications to the Bravo delivery device Primary Endpoints
- Evaluate physician subjective assessment questionnaire (appendix 3)
- Percentage of successful capsule attachments Patients will undergo standard-of-care Bravo pH procedure. Prior to the pH study, the patient should not eat or drink for a minimum of 6 hours, according to the standard system instructions.
- Bravo procedure may take 48-96 hours
- Patients will have a follow-up visit or call, one to two weeks after the procedure
- A fluoroscopy procedure may be ordered at physician's discretion to verify capsule attachment \ detachment from the patient's esophagus
Over all expected duration for subject's participation in the study will be a maximum of 1 month
Physician may be asked to provide feedback on the procedure usability and functionality and to document their activities during the procedure.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| pH monitoring procedure | Experimental | Device: Bravo pH monitoring procedureBravo pH monitoring procedure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Subject age ≥ 18 years old
- Subject received an explanation about the nature of the study and agrees to provide written informed consent.
- The subject was referred for pH monitoring procedure to detect acid reflux for at least one of the following reasons:
Key exclusion criteria (8 listed)
- 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
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 procedureBravo pH monitoring procedure | Device | pH monitoring procedure |
Primary outcome
Evaluate physician subjective assessment questionnaire
Time frame: post Bravo pH monitoring pinning procedure, same day of procedure
Percentage of successful capsule attachments
Time frame: post Bravo pH monitoring pinning procedure, same day of procedure
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
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.
Alexandra Lavy, Prof. principal investigator
Bnei Zion MC, HAifa, Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bravo pH monitoring procedure 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 13 inclusion and 8 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: withdrawn, 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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Evaluate physician subjective assessment questionnaire (time frame: post Bravo pH monitoring pinning procedure, same day of procedure). The study lists 2 primary outcomes in all. 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.