Esophageal and Gastric Diseases With Robotically Controlled Magnetic Capsule Endoscopy

Esophageal Diseases Clinical Trial

— MACEOES  

Official title:

Study of Esophageal and Gastric Diseases With Robotically Controlled Magnetic Capsule Endoscopy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04068480
• Other study ID #: BacsKiskunCTH
• Status: Recruiting
• Start date: November 15, 2017
• Est. completion date: January 31, 2024

Study information

• Verified date: August 2023
• Source: Bács-Kiskun County Teaching Hospital
• Contact: Milan Szalai, M.D.
• Phone: 0036203777818
• Email: dr.szalai.milan[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Magnetically controlled capsule endoscopy (MCCE) is an outstanding opportunity for the painless endoscopic screening of the esophagus and stomach before small bowel examiantion. Further improvement in patients positioning might increase the esophageal transit time of the capsule endoscope and could improve the sensitivity and specificity of the esophageal MCCE investigation. Our present study aimed to compare the visualization of the esophagus (especially the Z-line) with different capsule swallowing protocols.

Description:

Magnetic controlled capsule endoscope (MCCE) systems have been developed over the last 10-15 years to examine the upper GI tract, particularly the stomach. The new Navicam MACE system consists of a magnetic capsule endoscope, an external control magnet, a data recording kit and a computer workstation. With the appropriate software, allows real-time tracking and monitoring of the capsule inside the body. This method may in the near future be an optimal non-invasive method for screening gastric cancer and Barrett's oesophagus in high-risk populations. Esophagogastroduodenoscopy (EGD) is the gold standard diagnostic test, however it is very inconvenient for patients without sedation. The aim of our present study was a feasibility study to evaluate the safety and efficacy of Ankon MCCE for the investigation of esophageal abnormalities in patients referred for small bowel capsule endoscopy in our endoscopy department, to develop and test a method to use MCCE for esophageal examination, and to analyze the visualization of esophageal mucosa with our newly developed capsule swallowing protocol and manual capsule maneuvering.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: January 31, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• patients referred for small bowel capsule endoscopy in any indication

Exclusion Criteria:

• known or suspected stricture in the GI tract
• previous surgery with bowel anastomosis
• swallowing complaints
• dementia
• implanted cardioverter defibrillator
• inability to sign the informed consent

Related Conditions & MeSH terms

• Esophageal Diseases
• Stomach Diseases
• Video Capsule Endoscopy

Locations

Country	Name	City	State
Hungary	Endo-Kapszula Privat Medical Cenbter	Székesfehérvár

Sponsors (1)

Lead Sponsor	Collaborator
Bács-Kiskun County Teaching Hospital

Country where clinical trial is conducted

Hungary, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reflux esophagitis	Proportion and the severity of reflux (Los Angeles classification) comparing to gastroscopy	1 year
Primary	Diseases	Proportion of other disorders of oesophagus and stomach comparing to gastroscopy	1 year
Primary	Stomach examination	Analyze the visualisation of gastric mucosa with MACE system	1 year
Secondary	Restrain time	Analysing the correlation with MCCE system between esophageal transit time and diagnostic yield.	1 year
Secondary	Cleanliness	Analysis of stomach preparation with a special software concerning the percentage of clean and covered areas.	1 year