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

NCT03457909 | Completed Results

• 1 other identifier: DS-MCE-esophagus and stomach
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Outpatients

Keywords

string; capsule endoscopy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Number of DS-MCE Associated Adverse Events

  up to 2 weeks

• Duration of Time Capsule is Within the Esophagus

  up to 2 weeks

• Z-line Visualization

  up to 2 weeks

• Quality Score of Z-line Images

  up to 2 weeks

• Degree of Comfort

  up to 2 weeks

Study Arms (1)

DS-MCE

EXPERIMENTAL

outpatients who have esophagus symptoms will take DS-MCE and conventional endoscopy examination examination successively.

Device: DS-MCE

Interventions

DS-MCE DEVICE

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.

DS-MCE

Eligibility Criteria

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

You may qualify if:

• outpatients who have esophagus symptoms.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Changhai Hospital: lead

Study Sites (1)

Changhai Hospital

Shanghai, Shanghai Municipality, 200433, China

Location

Results Point of Contact

• Title: Changhai Hospital
• Organization: Department of Gastroenterology

liaozhuan@smmu.edu.cn

86-21-31161004

Study Officials

• Zhuan Liao

  Changhai Hospital

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor

Study Record Dates

• First Submitted: February 4, 2018
• First Posted: March 8, 2018
• Study Start: March 7, 2018
• Primary Completion: July 10, 2018
• Study Completion: August 1, 2018
• Last Updated: September 23, 2019
• Results First Posted: September 23, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)