MedTrace Logo

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

NCT01503476 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 170

Last updated 2019-07-31

No results posted yet for this study

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

Interventions

DEVICE

Bravo® pH Monitoring System

Bravo pH monitoring

DEVICE

Bravo® pH Monitoring System

Bravo pH monitoring

Sponsors & Collaborators

  • Medtronic - MITG

    lead INDUSTRY

Principal Investigators

  • Samuel Adler, M.D. · Bikur Holim medical center

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-02-29
Primary Completion
2016-03-31
Completion
2016-03-31

Countries

  • Israel

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01503476 on ClinicalTrials.gov