A New Method To Reduce Gastric Missing Areas in Capsule Endoscopy

Nanfang Hospital, Southern Medical University

Status: Unknown

Conditions: Capsule Endoscopy

Treatments: Behavioral: Position changing

Study type: Interventional

Funder types: Other

Identifiers

NCT02158260

capsule endoscopy20140107

Details and patient eligibility

About

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)

Full 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.

Enrollment: 71 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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71 participants in 2 patient groups

position changing

Experimental group

Description:

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.

Treatment:

Behavioral: Position changing

free position

No Intervention group