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临床试验/NCT00378898
NCT00378898已完成不适用

DUAL BRAVO PH MONITORING: A Feasibility Trial

Vanderbilt University Medical Center1 个研究点 分布在 1 个国家目标入组 39 人开始时间: 2006年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
39
试验地点
1
主要终点
Patients Requiring Endoscopic Removal of BRAVO Because of Reported Discomfort

研究概览

简要总结

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.

详细描述

24-hour pH monitoring is often considered the "gold standard" in the diagnosis of GERD and is increasingly utilized in patients with extra-esophageal symptoms (1). However, the clinical utility of pH monitoring in this patient population remains controversial. An important limitation of traditional pH catheters is their suboptimal sensitivity especially in patients with extraesophageal GERD. Vaezi et al. tested reproducibility and reliability of the proximal and distal esophageal pH probe in 32 patients (2). Among these patients,11 were controls, 10 had distal reflux, and 11 had both proximal and distal reflux. In this group of patients the sensitivity of distal and proximal pH probes were 70% and 55%, respectively. Additionally, a more recent study by Shaker et al. showed the number and duration of hypopharyngeal reflux events to be similar between the control subjects and patients with reflux laryngitis and vasomotor rhinitis (3).

Poor sensitivity of catheter based pH monitoring in detecting acid reflux may be due to day to day variability of test, its less than adequate reliability as well as possible intermittent nature of the reflux events (not recorded in only a 24-hour period) (4). Additionally, since the traditional ambulatory device is commonly placed transnasally through the oropharynx into the esophagus, patients often complain of throat and nose discomfort and usually restrict their daily activity. This potentially leads to false negative findings and reduced test sensitivity. Furthermore, incorrect results may be collected if the pH electrode slips away from the initial manometrically determined placement site. In light of these limitations, a new wireless (catheter free) pH monitoring device was developed to improve patient comfort and increase test sensitivity. The Bravo pH monitoring system (Medtronic Inc, Minneapolis, MN) uses a radiotelemetric capsule temporarily attached to the esophageal mucosa which transmits pH data to a receiver carried on patient's belt.

Although well studied in the distal esophagus, there are currently no studies in adults assessing the feasibility and patient tolerance to placement of this device more proximally. Such a placement may increase the sensitivity of the test and add to our ability to study potential predictors of treatment response in patients with extraesophageal GERD.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Inclusion criteria will include the following:
  • •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).

排除标准

  • •Exclusion criteria will include the following:
  • •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

研究组 & 干预措施

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.

干预措施: BRAVO capsule (Device)

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.

干预措施: Fluoroscopy (Procedure)

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.

干预措施: sham BRAVO capsule placement (Other)

结局指标

主要结局

Patients Requiring Endoscopic Removal of BRAVO Because of Reported Discomfort

时间窗: 48 hours

次要结局

  • Subjects Reporting Chest Pain(48 hours)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Michael Vaezi

Principal Investigator

Vanderbilt University Medical Center

研究点 (1)

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