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Completed

NCT Number: NCT03457909

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

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.

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Key information

Conditions

Outpatients

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Changhai Hospital

Shanghai, Shanghai Municipality, 200433, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Number of Participants With Successful Separation of Capsule and String, and Complete Viewing of Esophagus and Stomach

    Time frame: up to 2 weeks

    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.

Secondary outcomes

  1. Number of DS-MCE Associated Adverse Events

    Time frame: up to 2 weeks

    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.

  2. Duration of Time Capsule is Within the Esophagus

    Time frame: up to 2 weeks

    time from the capsule swallowed to the capsule entering the gastric cardia to examine the stomach

  3. Z-line Visualization

    Time frame: up to 2 weeks

    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.

  4. Quality Score of Z-line Images

    Time frame: up to 2 weeks

    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)

  5. Degree of Comfort

    Time frame: up to 2 weeks

    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).

Sponsors and collaborators

Lead sponsor

Changhai Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Mar 8, 2018
Registry last updated
Sep 23, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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