Clinical trial NCT02846155: Gastric Preparation of Magnetic-controlled Capsule Endoscopy
Official title: Gastric Preparation of Magnetic-controlled Capsule Endoscopy: A Prospective, Single Blinded and Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Stomach Diseases
Keywords: preparation
capsule endoscopy
Lead sponsor: Changhai Hospital
Sponsor class: OTHER
First posted: 2016-07-27
Enrollment: 120
Sex: ALL
Minimum age (years): 16
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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

Detailed description: 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.

Eligibility criteria: 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;
* Exclusion criteria for standard magnetic resonance imaging (MRI) examination such as the presence of surgical metallic devices, even though its low magnetic field would technically not interfere with such devices;
* Currently participating in another clinical study.

Primary outcomes:
measure: the level of gastric cleansing
timeFrame: 4 month
Secondary outcomes:
measure: Transit time
timeFrame: 4 month
measure: Diagnostic yield of Magnetic-controlled Capsule Endoscopy
timeFrame: 4 month
measure: Tolerability of participants
timeFrame: 4 month
measure: the visibility of gastric
timeFrame: 4 month
measure: the time of gastric examination
timeFrame: 4 month
measure: the added amount of water of the whole process during gastric examination
timeFrame: 4 month
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Changhai Hospital
city: Shanghai
country: China
facility: Changhai Hospital
Study officials:
References: