Magnetic-controlled Capsule Endoscopy vs. Gastroscopy for Detection of Gastric Diseases

Chronic Gastritis Clinical Trial

— MCE  

Official title:

Magnetic-controlled Capsule Endoscopy vs. Gastroscopy for Detection of Gastric Diseases: A Prospective Self-controlled Comparative Multicenter Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02219529
• Other study ID #: MCE-1
• Status: Completed
• Phase: Phase 3
• First received: August 12, 2014
• Last updated: July 19, 2015
• Start date: August 2014
• Est. completion date: February 2015

Study information

• Verified date: July 2015
• Source: Changhai Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

A new Magnetic-controlled Capsule Endoscopy (MCE) was developed by ANKON and got SFDA's approval in China in 2013. It has recently been evaluated to compare the diagnostic accuracy of MCE with that of standard gastroscopy for gastric diseases in 70 patients with encouraging results (In Press). To further testify the diagnostic accuracy of MCE for both the diffuse and focal diseases in stomach, we performed this single-blinded multi-center prospective study compared MCE with gastroscopy in patients with gastric symptoms and indication for upper GI Endoscopy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 350
• Est. completion date: February 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Patients presented with gastric symptoms and ready for the first Upper GI endoscopy

• Patients with known focal gastric diseases: gastric ulcer, gastric polyps, early gastric cancer, gastric stromal tumors and so on.

• Age of 18 years to 70 years

Exclusion Criteria:

• Patients with impaired bowel movement from ileus or organic digestive diseases

• Patients with known large and obstructing tumors of the upper GI tract

• Patients after upper GI surgery or abdominal surgery altering GI anatomy

• Patients under full anticoagulation

• Patient in poor general condition

• Patients using equipment that may be affected by radio transmission

• Patients using equipment that may be affected by magnetic field

• Pregnancy or suspected pregnancy

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Chronic Gastritis
• Early Gastric Cancer,
• Gastric Diseases,
• Gastric Polyps,
• Gastric Ulcer,
• Stomach Diseases
• Stomach Ulcer

Intervention

Device:
• MCE

• Standard gastroscopy

Locations

Country	Name	City	State
China	Shanghai Changhai Hospital	Shanghai

Sponsors (8)

Lead Sponsor	Collaborator
Changhai Hospital	Chinese PLA General Hospital, General Hospital of Beijing PLA Military Region, Nanfang Hospital of Southern Medical University, Peking Union Medical College Hospital, RenJi Hospital, Shandong Provincial Hospital, Wuhan Union Hospital, China

Country where clinical trial is conducted

China, 

References & Publications (2)

Liao Z, Duan XD, Xin L, Bo LM, Wang XH, Xiao GH, Hu LH, Zhuang SL, Li ZS. Feasibility and safety of magnetic-controlled capsule endoscopy system in examination of human stomach: a pilot study in healthy volunteers. J Interv Gastroenterol. 2012 Oct;2(4):155-160. Epub 2012 Oct 1. — View Citation

Liao Z, Gao R, Xu C, Li ZS. Indications and detection, completion, and retention rates of small-bowel capsule endoscopy: a systematic review. Gastrointest Endosc. 2010 Feb;71(2):280-6. doi: 10.1016/j.gie.2009.09.031. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of subjects diagnosed with gastric diffuse lesions by MCE Versus Standard Gastroscopy		2 days	No
Primary	Number of gastric focal lesions founded by MCE Versus Standard Gastroscopy		2 days	No
Secondary	Volume of water and drugs used for gastric preparation		1 hour	No
Secondary	Scores of the cleanliness of stomach after preparation		1 day	No
Secondary	Percentage of patients in whom there was complete visualization of the gastric surface in the antrum, body, and fundus and identification of the cardia and pylorus		1 day	No
Secondary	Examination times of MCE and standard gastroscopy		1 day	No
Secondary	Patient acceptance of MCE and standard gastroscopy		3 days	No
Secondary	Adverse events of both procedures		2 weeks	Yes

External Links

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