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

NCT01788085 | Withdrawn

• 1 other identifier: RD-41
• Study Type: interventional
• Target: N/A
• 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 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

Keywords

GERD

Outcome Measures

Primary Outcomes (2)

• Evaluate physician subjective assessment questionnaire

  post Bravo pH monitoring pinning procedure, same day of procedure

• Percentage of successful capsule attachments

  post Bravo pH monitoring pinning procedure, same day of procedure

Study Arms (1)

pH monitoring procedure

EXPERIMENTAL

Bravo pH monitoring procedure

Device: Bravo pH monitoring procedure

Interventions

Bravo pH monitoring procedure DEVICE

Bravo pH monitoring procedure

pH monitoring procedure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• 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.
• 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)
• Chest pain
• Cough
• Hoarseness
• Asthma
• Lower pharyngeal irritation, need to clear throat

You may not qualify if:

• 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)

Bnei-Zion MC

Haifa, Israel

Location

MeSH Terms

Conditions

Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

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

Study Officials

• Alexandra Lavy, Prof.

  Bnei Zion MC, HAifa, Israel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2013
• First Posted: February 11, 2013
• Study Start: August 1, 2013
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: July 31, 2019

Record last verified: 2019-07

Locations

IL (1)