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

RD-40 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 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.

Study Overview

• Status: Completed
• Conditions: Gastro Esophageal Reflux Disease
• Intervention / Treatment: Device: Bravo® pH Monitoring System

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.

• Study Type: Interventional
• Enrollment (Actual): 170
• Phase: Phase 4

Contacts and Locations

Study Locations

• Israel
  • Jerusalem, Israel
    • Bikur Holim medical center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 -

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Healthy volunteers; healthy volunteers	Device: Bravo® pH Monitoring System; Bravo pH monitoring; Other Names: pH monitoring
Experimental: symptomatic patients; symptomatic patients with known or suspected gastro esophageal reflux disease	Device: Bravo® pH Monitoring System; Bravo pH monitoring; Other Names: pH monitoring

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Medtronic - MITG
• Investigators: Principal Investigator: Samuel Adler, M.D., Bikur Holim medical center

Study record dates

Study Major Dates

• Study Start: February 1, 2012
• Primary Completion (Actual): March 1, 2016
• Study Completion (Actual): March 1, 2016

Study Registration Dates

• First Submitted: December 25, 2011
• First Submitted That Met QC Criteria: January 3, 2012
• First Posted (Estimate): January 4, 2012

Study Record Updates

• Last Update Posted (Actual): July 31, 2019
• Last Update Submitted That Met QC Criteria: July 29, 2019
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Keywords: gastro esophageal reflux disease
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastroesophageal Reflux
• Other Study ID Numbers: RD-40