NCT00378898

Brief Summary

Assessing the feasibility and patient tolerance to placement of Bravo PH capsule in proximal esophagus. There will be no difference in patient-perception of a proximally-placed Bravo esophageal pH monitor compared with a distal monitor.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2006

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2006

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

September 20, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 21, 2006

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
7.8 years until next milestone

Results Posted

Study results publicly available

April 4, 2017

Completed
Last Updated

April 4, 2017

Status Verified

March 1, 2017

Enrollment Period

2.5 years

First QC Date

September 20, 2006

Results QC Date

February 26, 2015

Last Update Submit

March 31, 2017

Conditions

Gastroesophageal Reflux Disease

Outcome Measures

Primary Outcomes (1)

  • Patients Requiring Endoscopic Removal of BRAVO Because of Reported Discomfort

    48 hours

Secondary Outcomes (1)

  • Subjects Reporting Chest Pain

    48 hours

Study Arms (2)

EGD with proximal BRAVO capsule

ACTIVE COMPARATOR

Subjects have a second BRAVO capsule placed 10cm proximal to prior BRAVO capsule placement. Fluoroscopy is used to confirm detachment of the monitor 7 days after investigational deployment.

Device: BRAVO capsuleProcedure: Fluoroscopy

EGD with sham BRAVO capsule placement

SHAM COMPARATOR

Subjects have a EGD with BRAVO delivery introducer positioned 10cm proximal to prior BRAVO capsule placement with no BRAVO placed.

Other: sham BRAVO capsule placement

Interventions

BRAVO capsuleDEVICE
EGD with proximal BRAVO capsule
FluoroscopyPROCEDURE

one time "xray" to determine evacuation of bravo

Also known as: one time "xray" to determine evacuation of bravo
EGD with proximal BRAVO capsule
sham BRAVO capsule placementOTHER
EGD with sham BRAVO capsule placement

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients greater than or equal to 18 years of age
  • Patients having regularly scheduled upper endoscopy with planned Bravo pH monitor testing
  • Patients with known GERD based on symptoms (heartburn, regurgitation) and response to a proton pump inhibitor or esophagitis on EGD as well as those with extraesophageal GERD (cough, asthma and throat discomfort).

You may not qualify if:

  • Previous surgical procedures to the upper esophagus
  • History of bleeding diathesis or coagulopathy
  • Stroke or transient ischemic attack within the past 6 months
  • GI bleeding within the previous 6 months
  • Known esophageal varices
  • Significant medical illness (i.e., congestive heart failure)
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Vanderbilt Clinic/ Endoscopy Lab

Nashville, Tennessee, 37232-5280, United States

Location

MeSH Terms

Conditions

Gastroesophageal Reflux

Interventions

Drug Implants

Condition Hierarchy (Ancestors)

Esophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Delayed-Action PreparationsDosage FormsPharmaceutical Preparations

Limitations and Caveats

Selection bias may have been a limitation, as patients volunteering may have had worse symptoms and potentially altered esophageal sensitivity as compared to those who opted not to participate.

Results Point of Contact

Title
Dr. Michael Vaezi
Organization
Vanderbilt University Medical Center
michael.vaezi@vanderbilt.edu
615-322-3739

Study Officials

  • Michael F Vaezi, MD, PhD

    Vanderbilt University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 20, 2006

First Posted

September 21, 2006

Study Start

September 1, 2006

Primary Completion

March 1, 2009

Study Completion

July 1, 2009

Last Updated

April 4, 2017

Results First Posted

April 4, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)