A New Method To Reduce Gastric Missing Areas in Capsule Endoscopy

June 5, 2014 updated by: Side Liu, Nanfang Hospital of Southern Medical University

A New Method To Reduce Gastric Missing Areas in Capsule Endoscopy: a Single Center, Prospective and Self-controlled Trial

It is a single center, prospective and self-controlled trial. We'd like to explore a new method by changing position to reduce gastric missing areas in Capsule Endoscopy(CE)

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Background:Capsule endoscopy is widely used to observe small intestine.While it may miss important areas in stomach,especially in fundus.So far,physicians have no methods to observe stomach without no-missing areas by capsule endoscopy.

Objective:To explore a new method to reduce the areas missed by CE.

Methods:Subjects were prospectively enrolled.Every subjects will undergo 2 capsule endoscopies and 1 gastroscope.First capsule endoscopy,every subject have a better gastric preparation before swallowing CE and change position during the procedure.Second capsule endoscopy,every subject have a conventional CE. And then, every subject have a gastroscope.

Measurements:The primary measurements included safety, gastric preparation, visualization of gastric mucosa and rate of lesion detection.

Study Type

Interventional

Enrollment (Anticipated)

71

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • Guangdong
      • Guangzhou, Guangdong, China, 510515
        • Recruiting
        • Nanfang Hospital
        • Contact:
          • Zelong Han, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subjects don't have swallowing difficulties, motility disorders, or a medical history that included abdominal surgery or obvious gastrointestinal strictures are included.

Exclusion Criteria:

  • Subjects with swallowing difficulty, motility disorders, diabetes, life-threatening conditions, mental disorders, or patients that could be pregnant, have a cardiac pacemaker, electrical implant, or any other condition that would preclude compliance with the study requirements and/or device instructions are excluded from the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: position changing
During the examination, subjects changed position in the following sequence: left lateral head-down position, supine position, prone head-down position, right lateral head-down position, supine position, left lateral position, prone position, prone hip-high position, right lateral position and sitting position.
No Intervention: free position

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
visualization of gastric mucosa
Time Frame: 1 year
Gastric preparation included the degree of cleanliness and distention.Cleanliness was evaluated by 3 grades: good (the fluid was transparent and <5% of gastric mucosa was obscured by stomach contents), moderate (the fluid was a little opaque or 5% to 10% of gastric mucosa was obscured by stomach contents) and poor (the fluid was opaque or >10% of gastric mucosa was obscured by stomach contents). Distention was evaluated by 3 grades: good (existence of a small amount of gastric folds), moderate (existence of significant amount of gastric folds and gastric cavity was smaller than expected) and poor (gastric cavity was not inflated).
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
rate of lesion detection
Time Frame: 1 year
Gastroscope is the golden standard in diagnosing gastric diseases.we defined rate of lesion detection as the lesions detected by CE compared to gastroscope.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Side Liu, phD, Nanfang Hospital of Southern Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (Anticipated)

June 1, 2015

Study Registration Dates

First Submitted

May 31, 2014

First Submitted That Met QC Criteria

June 5, 2014

First Posted (Estimate)

June 6, 2014

Study Record Updates

Last Update Posted (Estimate)

June 6, 2014

Last Update Submitted That Met QC Criteria

June 5, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Other Study ID Numbers

  • capsule endoscopy20140107

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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