Comparative Study of the Magnetic-controlled Capsule Endoscopy Versus Standard Gastroscopy

NCT01903629 | Completed Phase 1 DMC

• 1 other identifier: AKE-1
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

Passive video capsule endoscopy is the criterion standard for small-bowel diseases but cannot be used for the large gastric cavity.This blinded prospective study investigates the accuracy of the magnetic-controlled capsule endoscopy compared to gastroscopy in patients with gastric symptoms and indication for upper GI Endoscopy.

Conditions

Gastric Symptoms; Indicated for Upper GI Endoscopy

Outcome Measures

Primary Outcomes (1)

• Accuracy of magnetic-controlled capsule endoscopy(MCE) Versus Standard Gastroscopy in the diagnosis of diffuse and local lesions

  2 days

Secondary Outcomes (3)

• Examination times of capsule and standard gastroscopy

  1 hour

• Patient acceptance of capsule gastroscopy and standard gastroscopy

  3 days

• Adverse events of both procedures

  2 weeks

Study Arms (1)

magnetic-controlled capsule endoscocpy (MCE)

EXPERIMENTAL

patients were assigned to swallow MCE first, followed by the gastroscopy

Device: MCE; Device: Standard gastroscopy

Interventions

MCE DEVICE

MCE first, followed by standard gastroscopy

magnetic-controlled capsule endoscocpy (MCE)

Standard gastroscopy DEVICE

magnetic-controlled capsule endoscocpy (MCE)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with gastric symptoms and indicated for Upper GI endoscopy
• Age of 18 years to 70 years

You may not qualify if:

• 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

Sponsors & Collaborators

• Changhai Hospital: lead
• Second Military Medical University: collaborator
• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology: collaborator

Study Sites (1)

Shanghai Changhai Hospital

Shanghai, 200433, China

Location

Related Publications (3)

• 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-Dec;2(4):155-160. doi: 10.4161/jig.23751. Epub 2012 Oct 1.

  PMID: 23687601 BACKGROUND

• 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.

  PMID: 20152309 BACKGROUND

• Zou WB, Hou XH, Xin L, Liu J, Bo LM, Yu GY, Liao Z, Li ZS. Magnetic-controlled capsule endoscopy vs. gastroscopy for gastric diseases: a two-center self-controlled comparative trial. Endoscopy. 2015 Jun;47(6):525-8. doi: 10.1055/s-0034-1391123. Epub 2015 Jan 15.

  PMID: 25590177 DERIVED

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Gastroenterology Dept.

Study Record Dates

• First Submitted: July 17, 2013
• First Posted: July 19, 2013
• Study Start: November 1, 2011
• Primary Completion: December 1, 2012
• Study Completion: February 1, 2013
• Last Updated: July 21, 2015

Record last verified: 2015-07

Locations

CN (1)