Gastric Preparation of Magnetic-controlled Capsule Endoscopy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-31

Study Completion Date

2016-12-31

Brief Summary

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By using three different Gastric Preparation of Magnetic-controlled Capsule Endoscopy, the investigators hope to find out the optimal gastric preparation plan.

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Detailed Description

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It is a prospective, single-blind, randomized controlled trial. Patients who were conducted by Magnetic-controlled Capsule Endoscopy at Changhai Hospital will be randomly allocated into three different Gastric Preparation group before the procedure. It include clear water group which patient only drink 1000ml clear water before checking; simethicone group which patient drink 950ml clear water and 15ml simethicone before checking; simethicone combined with pronase group which patient drink 900ml lear water and 15ml simethicone and 20，000iu pronase before checking. The result were got from a relevant professional physician's blinded independent image-reading.

Conditions

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Stomach Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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clear water group

the patients only drink 1000ml clear water before checking

Group Type PLACEBO_COMPARATOR

clear water

Intervention Type OTHER

the patients just drink common clear water before Magnetic-controlled Capsule Endoscopy examination

simethicone group

the patients drink 950ml clear water and 15ml simethicone before checking

Group Type EXPERIMENTAL

simethicone

Intervention Type DRUG

the patients drink clear water and simethicone (Espumisan; Berlin-Chemie, Germany, containing 40 mg simethicone in 1 mL emulsion) before Magnetic-controlled Capsule Endoscopy examination

simethicone combined with pronase group

the patients drink 900ml clear water and 15ml simethicone and 20，000iu pronase before checking

Group Type EXPERIMENTAL

simethicone combined with pronase

Intervention Type DRUG

the patients drink simethicone (Espumisan; Berlin-Chemie, Germany, containing 40 mg simethicone in 1 mL emulsion)，pronase granules（Deyou；Beijing Tide Pharmaceutical Co，China,containing 20,000iu pronase），and clear water before Magnetic-controlled Capsule Endoscopy examination

Interventions

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clear water

the patients just drink common clear water before Magnetic-controlled Capsule Endoscopy examination

Intervention Type OTHER

simethicone

the patients drink clear water and simethicone (Espumisan; Berlin-Chemie, Germany, containing 40 mg simethicone in 1 mL emulsion) before Magnetic-controlled Capsule Endoscopy examination

Intervention Type DRUG

simethicone combined with pronase

the patients drink simethicone (Espumisan; Berlin-Chemie, Germany, containing 40 mg simethicone in 1 mL emulsion)，pronase granules（Deyou；Beijing Tide Pharmaceutical Co，China,containing 20,000iu pronase），and clear water before Magnetic-controlled Capsule Endoscopy examination

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Adult patients aged 16-75 years, who were scheduled to undergo a Magnetic-controlled Capsule Endoscopy, were eligible for this study.

Exclusion Criteria

* Dysphagia or symptoms of gastric outlet obstruction, suspected or known intestinal stenosis, overt gastrointestinal bleeding, history of upper gastrointestinal surgery or abdominal surgery altering gastrointestinal anatomy, or postabdominal radiation;
* Congestive heart failure, renal insufficiency, under therapeutic anticoagulation, in poor general condition (American Society of Anesthesiologists class III/IV), claustrophobia, metallic parts, a pacemaker or other implanted electromedical devices, artificial heart valves;
* Pregnancy or suspected pregnancy;
* Currently participating in another clinical study.

Minimum Eligible Age

16 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes