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Enhancing Detection of Small Esophageal Varices by PillCam ESO

NCT00911131 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2015-06-19

No results posted yet for this study

Summary

Increasing intra-abdominal pressure (IAP) with an abdominal binder will increase pressure within smaller esophageal varices which will therefore enhance the ability of capsule endoscopy to detect these varices better.

Therefore, the aims of the investigators' study are as follows:

1. To determine if using an abdominal binder to increase IAP can increase the detection rate of small esophageal varices when using capsule endoscopy.
2. To determine if using an abdominal binder to increase IAP during capsule endoscopy has a comparable detection rate of small esophageal varices to conventional endoscopy.

Conditions

  • Esophageal Varices

Interventions

DEVICE

Capsule endoscopy (PillCam ESO)

The capsule endoscope is placed in the mouth and the patient is asked to swallow it with 100cc of water with simethicone in the supine position. Recording is done for 2 minute in this position and then the head is elevated to 30 degrees for 2 minutes and then 60 degrees for 1 minute. After 1 minute, the patient sips 10cc of water and after 15 seconds, they sit upright and sip water again. They can then walk and resume normal activity for 15 minutes.

PROCEDURE

EGD

Patients will undergo conventional EGD under conscious sedation for routine screening of esophageal varices.

DEVICE

Capsule endoscopy (PillCam ESO) with abdominal binder

An abdominal binder with and inflatable girdle is wrapped around the stomach prior to swallowing the capsule endoscope. The girdle is inflated to 10mmHg for 10 minutes. The capsule is swallowed by the patient and the routine method for the procedure is performed.

Sponsors & Collaborators

  • Medtronic - MITG

    collaborator INDUSTRY

  • Medical College of Wisconsin

    lead OTHER

Principal Investigators

  • Kia Saeian, MD · Medical College of Wisconsin

  • Mukund Venu, MD · Medical College of Wisconsin

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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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 NCT00911131 on ClinicalTrials.gov