NCT01788085

Withdrawn

Development of Applications of the Bravo® pH Monitoring Syst...

Medtronic - MITG Source

Compare

Other study identifiers

Sponsor study identifier

RD-41

Study Type

interventional

Actual enrollment (reported)

0

Locations

1 country

Sites

1

Timeline

Study Start

August 2013

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

March 2014

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Study Completion

March 2014

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: withdrawn
Actual enrollment (reported): 0 participants
Study completion date: March 2014
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

First Submitted
February 5, 2013
Actual (reported)
First Posted
February 11, 2013
Actual (reported)
Study Start
August 2013
Date type not reported
This date has not been verified as actual or estimated.
Primary Completion
March 2014
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
March 2014
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.

Last Updated: July 31, 2019
Status Verified: July 2019
Last Update Submitted: July 29, 2019

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 procedureDevice

Bravo pH monitoring procedure

pH monitoring procedure

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (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.

Sponsors & Collaborators

Medtronic - MITG
Industrylead

Study Sites (1)

Bnei-Zion MC

Haifa, Israel

MeSH Terms

Conditions

Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Esophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Officials

Alexandra Lavy, Prof.
Bnei Zion MC, HAifa, Israel
PRINCIPAL INVESTIGATOR

Enrollment

0 participants (actual enrollment reported by the registry).

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 2013

Date type not reported

This date has not been verified as actual or estimated.

NCT02154659

The Difference of Reflux Pattern Between the Patients Who Have Postprandial Reflux Symptoms

Not ApplicableCompleted

NCT05696184

Mechanisms Preventing Pharyngeal Reflux

Not ApplicableRecruiting

NCT02114216

Nociceptors, Neurotrophic Factors and Cytokine Expression in Gastroesophageal Reflux Disease

Not ApplicableCompleted

NCT01798212

Prospective Trial on the Clinical Feasibility of a New Full Thickness Endoscopic Plication Device for Patients With GERD.

Not ApplicableCompleted

NCT02124863

Influence of IPV on GOR in Infants From 0 to 12 Months.

Not ApplicableCompleted

NCT01364610

An Assessment of pH Testing Methods

Not ApplicableCompleted

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

Contact the study team to confirm eligibility.

Primary Completion

March 2014

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Study Completion

March 2014

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Last Updated

July 31, 2019

Record last verified: 2019-07

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT01788085
Data provider: ClinicalTrials.gov
Source updated: 2019-07-31
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:38:41 UTC

Locations

IL(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Study Arms (1)

pH monitoring procedure

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations