RD-40 Development of Applications of the Bravo® pH Monitoring System and Evaluation of Its Performance
Sponsor study identifier
interventional
170
1 country
1
Study Start
February 2012
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
March 2016
Actual (reported)Study Completion
March 2016
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 2016
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 25, 2011
Actual (reported)January 4, 2012
Actual (reported)February 2012
Date type not reportedThis date has not been verified as actual or estimated.
March 2016
Actual (reported)March 2016
Actual (reported)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)
up to 96 hours
healthy volunteers
symptomatic patients with known or suspected gastro esophageal reflux disease
Bravo pH monitoring
Bravo pH monitoring
Bikur Holim medical center
Jerusalem, Israel
Samuel Adler, M.D.
Bikur Holim medical center
170 participants (actual enrollment reported by the registry).
First Submitted
December 25, 2011
First Posted
January 4, 2012
Study Start
February 2012
Date type not reportedThis date has not been verified as actual or estimated.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
March 2016
Actual (reported)Study Completion
March 2016
Actual (reported)Last Updated
July 31, 2019
Record last verified: 2015-07
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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