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Development of Applications of the Bravo® pH Monitoring System and Evaluation of Its Performance

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ClinicalTrials.gov Identifier: NCT01503476
Recruitment Status : Completed
First Posted : January 4, 2012
Last Update Posted : July 31, 2019
Sponsor:
Information provided by (Responsible Party):
Medtronic - MITG

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 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.


Condition or disease Intervention/treatment Phase
Gastro Esophageal Reflux Disease Device: Bravo® pH Monitoring System Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 170 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: RD-40 Development of Applications of the Bravo® pH Monitoring System and Evaluation of Its Performance
Study Start Date : February 2012
Actual Primary Completion Date : March 2016
Actual Study Completion Date : March 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: GERD

Arm Intervention/treatment
Experimental: Healthy volunteers
healthy volunteers
Device: Bravo® pH Monitoring System
Bravo pH monitoring
Other Name: pH monitoring

Experimental: symptomatic patients
symptomatic patients with known or suspected gastro esophageal reflux disease
Device: Bravo® pH Monitoring System
Bravo pH monitoring
Other Name: pH monitoring




Primary Outcome Measures :
  1. 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)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Subject age ≥ 18 years old
  2. Subject received an explanation about the nature of the study and agrees to provide written informed consent.

    Group A (healthy volunteers) Only

  3. 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)
  • Regurgitation of food or stomach contents
  • Dysphagia
  • Epigastric pain
  • Non-erosive reflux disease (NERD)

Exclusion Criteria:

Group A and B-

  1. Subject has a cardiac pacemaker or other implanted electromedical device.
  2. Subject has any condition, which precludes compliance with study and/or device instructions.
  3. 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.
  4. Subject suffers from life threatening conditions
  5. Subject currently participating in another clinical study which may interfere with study objectives, per physician discretion

    Additional exclusion criteria for Group B only

  6. 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
  7. Subject is schedule to undergo MRI examination within 30 days from pH monitoring procedure.
  8. Subject has known bleeding diathesis, strictures, severe esophagitis, varices and or obstructions -

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01503476


Locations
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Israel
Bikur Holim medical center
Jerusalem, Israel
Sponsors and Collaborators
Medtronic - MITG
Investigators
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Principal Investigator: Samuel Adler, M.D. Bikur Holim medical center

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Responsible Party: Medtronic - MITG
ClinicalTrials.gov Identifier: NCT01503476     History of Changes
Other Study ID Numbers: RD-40
First Posted: January 4, 2012    Key Record Dates
Last Update Posted: July 31, 2019
Last Verified: July 2015
Keywords provided by Medtronic - MITG:
gastro esophageal reflux disease
Additional relevant MeSH terms:
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Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases