Back to resultsDevelopment of Applications of the Bravo® pH Monitoring System and Evaluation of Its Performance (Encore)
Primary Purpose
Gastro Esophageal Reflux Disease
Status
Withdrawn
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Bravo pH monitoring procedure
Sponsored by
About this trial
This is an interventional diagnostic trial for Gastro Esophageal Reflux Disease focused on measuring GERD
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.
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
Sites / Locations
- Bnei-Zion MC
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
pH monitoring procedure
Arm Description
Bravo pH monitoring procedure
Outcomes
Primary Outcome Measures
Evaluate physician subjective assessment questionnaire
Percentage of successful capsule attachments
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01788085
Brief Title
Development of Applications of the Bravo® pH Monitoring System and Evaluation of Its Performance (Encore)
Official Title
RD-41 Development of Applications of the Bravo® pH Monitoring System and Evaluation of Its Performance
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Withdrawn
Study Start Date
August 2013 (undefined)
Primary Completion Date
March 2014 (Anticipated)
Study Completion Date
March 2014 (Anticipated)
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastro Esophageal Reflux Disease
Keywords
GERD
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
pH monitoring procedure
Arm Type
Experimental
Arm Description
Bravo pH monitoring procedure
Intervention Type
Device
Intervention Name(s)
Bravo pH monitoring procedure
Intervention Description
Bravo pH monitoring procedure
Primary Outcome Measure Information:
Title
Evaluate physician subjective assessment questionnaire
Time Frame
post Bravo pH monitoring pinning procedure, same day of procedure
Title
Percentage of successful capsule attachments
Time Frame
post Bravo pH monitoring pinning procedure, same day of procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexandra Lavy, Prof.
Organizational Affiliation
Bnei Zion MC, HAifa, Israel
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bnei-Zion MC
City
Haifa
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 (Encore)
We'll reach out to this number within 24 hrs