Gastric Preparation of Magnetic-controlled Capsule Endoscopy

NCT02846155 | Unknown Phase 2 DMC

• 1 other identifier: 20160410A
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Stomach Diseases

Keywords

preparation; capsule endoscopy

Outcome Measures

Primary Outcomes (1)

• the level of gastric cleansing

  Two investigators who did not know which kind of gastric preparation of the patient scored the level of gastric cleansing 0f 120 participants according to a four-point grading scale: poor, fair, good, and excellent，which was pointed 3,2,1，and 0.The investigators should evaluate the gastric cleansing of six anatomical landmarks (cardia, fundus, body, angulus, antrum and pylorus).A poor level of cleansing indicated the mucosa was obscured largely by a lot of air bubbles and grume,fair indicated that a portion of the mucosa was obscured by air bubbles and grume that was enough to prevent a reliable visualization of polyps, good indicated that a small amount of air bubbles and grume，and excellent indicated that the fluid was clear and the image was either free or had only small bits of air bubbles and grume.

  4 month

Secondary Outcomes (6)

• Transit time

  4 month

• Diagnostic yield of Magnetic-controlled Capsule Endoscopy

  4 month

• Tolerability of participants

  4 month

• the visibility of gastric

  4 month

• the time of gastric examination

  4 month

Study Arms (3)

clear water group

PLACEBO COMPARATOR

the patients only drink 1000ml clear water before checking

Other: clear water

simethicone group

EXPERIMENTAL

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

Drug: simethicone

simethicone combined with pronase group

EXPERIMENTAL

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

Drug: simethicone combined with pronase

Interventions

clear water OTHER

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

clear water group

simethicone 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 group

simethicone combined with pronase 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

simethicone combined with pronase group

Eligibility Criteria

• Age: 16 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Changhai Hospital: lead

Study Sites (2)

Changhai Hospital

Shanghai, China

RECRUITING

Changhai Hospital

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Stomach Diseases

Interventions

Simethicone; Pronase

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Dimethylpolysiloxanes; Silicones; Siloxanes; Organosilicon Compounds; Organic Chemicals; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Serine Endopeptidases; Metalloproteases; Serine Proteases

Central Study Contacts

Zhuan Liao

CONTACT

liaozhuan@smmu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D., Associate Professor, Associate Chief Physician

Study Record Dates

• First Submitted: July 21, 2016
• First Posted: July 27, 2016
• Study Start: May 1, 2016
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: July 27, 2016

Record last verified: 2016-07

Locations

CN (2)