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

NCT01788085 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

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 symptomatic patients with known or suspected gastroesophageal reflux disease

Symptomatic patients will undergo invasive procedure, including Bravo capsule delivery, positioning and attachment. Confirmation of capsule attachment may be done endoscopically.

These procedures will serve to evaluate overall system performance in actual clinical setup, for instance: ergonomics and performance of delivery device, capsule transmission etc.

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 procedure

Bravo pH monitoring procedure

Sponsors & Collaborators

  • Medtronic - MITG

    lead INDUSTRY

Principal Investigators

  • Alexandra Lavy, Prof. · Bnei Zion MC, HAifa, Israel

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-08-31
Primary Completion
2014-03-31
Completion
2014-03-31

Countries

  • Israel

Study Locations

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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 NCT01788085 on ClinicalTrials.gov