- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01788085
Development of Applications of the Bravo® pH Monitoring System and Evaluation of Its Performance (Encore)
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
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Haifa, Israel
- Bnei-Zion MC
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
- Epigastric pain
- Non-erosive reflux disease (NERD)
- Chest pain
- Cough
- Hoarseness
- Asthma
- Lower pharyngeal irritation, need to clear throat
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: pH monitoring procedure
Bravo pH monitoring procedure
|
Bravo pH monitoring procedure
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Evaluate physician subjective assessment questionnaire
Time Frame: post Bravo pH monitoring pinning procedure, same day of procedure
|
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
|
post Bravo pH monitoring pinning procedure, same day of procedure
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Alexandra Lavy, Prof., Bnei Zion MC, HAifa, Israel
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- RD-41
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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