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

NCT01503476 | Completed Phase 4

• 1 other identifier: RD-40
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastro Esophageal Reflux Disease

Keywords

gastro esophageal reflux disease

Outcome Measures

Primary Outcomes (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)

  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

Study Arms (2)

Healthy volunteers

EXPERIMENTAL

healthy volunteers

Device: Bravo® pH Monitoring System

symptomatic patients

EXPERIMENTAL

symptomatic patients with known or suspected gastro esophageal reflux disease

Device: Bravo® pH Monitoring System

Interventions

Bravo® pH Monitoring System DEVICE

Bravo pH monitoring

Also known as: pH monitoring

symptomatic patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject age ≥ 18 years old
• Subject received an explanation about the nature of the study and agrees to provide written informed consent.
• Group A (healthy volunteers) Only
• 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)

You may not qualify if:

• Group A and B-
• 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 -

Sponsors & Collaborators

• Medtronic - MITG: lead

Study Sites (1)

Bikur Holim medical center

Jerusalem, Israel

Location

MeSH Terms

Conditions

Gastroesophageal Reflux

Interventions

Esophageal pH Monitoring

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Monitoring, Physiologic

Study Officials

• Samuel Adler, M.D.

  Bikur Holim medical center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 25, 2011
• First Posted: January 4, 2012
• Study Start: February 1, 2012
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: July 31, 2019

Record last verified: 2015-07

Locations

IL (1)