Detachable String Magnetically Controlled Capsule Endoscopy for Completely Viewing of Esophagus and Stomach

Outpatients Clinical Trial

Official title:

A Novel Detachable String Magnetically Controlled Capsule Endoscopy (DS-MCE) for Viewing Esophagus and Stomach

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03457909
• Other study ID #: DS-MCE-esophagus and stomach
• Status: Completed
• Phase: N/A
• Start date: March 7, 2018
• Est. completion date: August 1, 2018

Study information

• Verified date: August 2019
• Source: Changhai Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to determine the safety and feasibility of the new technique,detachable string magnetically controlled capsule endoscopy(DS-MCE)for evaluating gastric and esophagus diseases.

Description:

Esophageal capsule endoscopy(ECE)provides a novel noninvasive approach to visualize the esophagus.The main drawback for the use of ECE is its unreliable transit time which often renders an inadequate visualization of the esophagus.Thus investigators have developed the detachable string magnetically controlled capsule endoscopy(DS-MCE) which can control the movement of the capsule through the string.

This study is a prospective, single-centered, self-controlled pilot study.Outpatients who have esophagus symptoms will take conventional endoscopy examination and DS-MCE successively.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: August 1, 2018
• Est. primary completion date: July 10, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• outpatients who have esophagus symptoms.

Exclusion Criteria:

• known or suspected complex history of gastrointestinal obstruction, stenosis or fistula.

• dysphagia or delayed gastric emptying.

• known or suspected possibility of active bleeding of digestive tract.

• a history of abdominal operation.

• pacemaker implantation and gastrointestinal pacemaker users.

• patients who are allergic to simethicone or pronase.

• pregnant women,mental patients.

• other circumstances that doctors consider inappropriate for the study.

Related Conditions & MeSH terms

• Outpatients

Intervention

Device:
• DS-MCE
During the DS-MCE examination,the capsule is allowed to travel down into gastric cardia,from where the string is slowly pulled to allow the capsule to view the esophagus retrogradely.

Locations

Country	Name	City	State
China	Changhai Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Changhai Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Successful Separation of Capsule and String, and Complete Viewing of Esophagus and Stomach	evaluate the feasibility of the novel DS-MCE examination. The successful separation of the capsule and string was evaluated by the capsule entering the stomach and and the string being pulled out.Complete viewing of esophagus and stomach was evaluated by completing the procedure from the capsule being swallowed, the esophagus observed retrograde, to the string being pulled out after separating from the capsule.This primary outcome indicated how many participatns completed the DS-MCE examination successfully.	up to 2 weeks
Secondary	Number of DS-MCE Associated Adverse Events	evaluate the safety of DS-MCE.Record any adverse event during the procedure and after the procedure.Patients will be followed up by telephone to inquire about the symptoms of abdominal distention, abdominal pain,vomiting and other discomfort. Follow up to the end of the capsule expulsion.	up to 2 weeks
Secondary	Duration of Time Capsule is Within the Esophagus	time from the capsule swallowed to the capsule entering the gastric cardia to examine the stomach	up to 2 weeks
Secondary	Z-line Visualization	Z-line represents the normal esophagogastric junction where the squamous mucosa of the esophagus and columnar mucosa of the stomach meet.We can devide the Z-line into four quadrants under capsule endoscopy. Observing all the four quadrants is considered to be a complete observation of Z-line. In this study,the number of participants with at least two quadrants of Z-line visualized was used to evaluate the Z-line visulization.	up to 2 weeks
Secondary	Quality Score of Z-line Images	grade (mild, moderate,and severe) of air-bubble and saliva interference on the Z-line view(0, no intraluminal gas bubble; 1, a few gas bubbles, no limitation of interpretation; 2, an increased amount of intraluminal foam/gas bubbles, moderate limitation of visibility; 3, an amount of foam/gas bubbles)	up to 2 weeks
Secondary	Degree of Comfort	evaluate patient's degree of comfort throughout the procedure.Patients will be asked to fill in a questionnaire to give scores about degree of comfort throughout the procedure.Overall discomfort was scored on a scale of 0 to 10 (0, no discomfort; 10, the overall discomfort of EGD).	up to 2 weeks