Magnetic Steering Improves Small Bowel Capsule Endoscopy Completion Rate

May 1, 2018 updated by: Zhuan Liao

Magnetic Steering of Capsule Endoscopy Improves Small Bowel Capsule Endoscopy Completion Rate

Patients referred for magnetically controlled capsule endoscopy (MCE) in the participating center from June 2017 to November 2017 were prospectively enrolled. Magnetic steering of MCE was performed after standard gastric examination. Capsule endoscopy completion rate (CECR), gastric transit time (GTT), pyloric transit time (PTT) and rapid gastric transit rate (GTT ≤ 30 min) were compared with the historical control group enrolled from January 2017 to May 2017.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Background and aims: Capsule endoscopy is currently available as a noninvasive and effective diagnostic modality to identify small bowel abnormalities, while the completion rate ranged from 75.1% to 95.6%. A novel magnetically controlled capsule endoscopy (MCE) system could facilitate the capsule to pass through pylorus thereby reducing the gastric transit time (GTT). The investigators perform this study to determine the potential improvement in capsule endoscopy completion rate (CECR) under magnetic steering vs standard mode.

Methods: Patients referred for magnetically controlled capsule endoscopy (MCE) in the participating center from June 2017 to November 2017 were prospectively enrolled. Magnetic steering of MCE was performed after standard gastric examination. Capsule endoscopy completion rate (CECR), gastric transit time (GTT), pyloric transit time (PTT) and rapid gastric transit rate (GTT ≤ 30 min) were compared with the historical control group enrolled from January 2017 to May 2017.

Study Type

Interventional

Enrollment (Actual)

227

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Shanghai, China
        • Shanghai Changhai Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adult patients aged over 18
  • With gastrointestinal complaints
  • Scheduled to undergo a capsule endoscopy for both stomach and small bowel

Exclusion Criteria:

  • No surgical condition or refusing abdominal surgery to take out the capsule in case of capsule retention
  • Implanted pacemaker, except the pacemaker is compatible with MRI
  • Other implanted electromedical devices or magnetic metal foreign bodies
  • Pregnancy or suspected pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: Control
The patients swallowed the capsule with water in the supine position. When the capsule reached the stomach, the capsule was lifted away from the posterior wall, rotated and advanced to the fundus and cardiac regions, and then to the gastric body, angulus, antrum and pylorus. After completing the stomach examination, the capsule moved automatically without magnetic control and entered the duodenum under physiological conditions. The position of the capsule was verified through real-time viewer.
EXPERIMENTAL: Magnetic steering
After finishing the stomach examination as the control protocol, the capsule was lifted with the magnetic control, then rotating the capsule until the camera end oriented toward the pylorus . Next, the endoscopist could drag the capsule close to the pylorus with the guidance magnet robot, waiting for the open of pylorus. Once the pylorus opened, the capsule could enter the duodenum with gastric peristalsis.
Other: magnetic steering
The capsule was controlled to pass through the pylorus by magnet steering.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CECR
Time Frame: Two weeks
Capsule endoscopy completion rate
Two weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic cases by MCE
Time Frame: Two weeks
Esophageal, gastric, small bowel and colon diseases diagnosed by MCE
Two weeks
Transit time
Time Frame: Two weeks
Esophageal/gastric/pyloric/small bowel/total transit time
Two weeks
Rapid gastric transit rate
Time Frame: Two weeks
Rate of patients with a gastric transit time of ≤ 30 min
Two weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zhuan Liao

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 1, 2017

Primary Completion (ACTUAL)

November 30, 2017

Study Completion (ACTUAL)

November 30, 2017

Study Registration Dates

First Submitted

March 5, 2018

First Submitted That Met QC Criteria

March 28, 2018

First Posted (ACTUAL)

March 29, 2018

Study Record Updates

Last Update Posted (ACTUAL)

May 3, 2018

Last Update Submitted That Met QC Criteria

May 1, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MCE-CECR

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

We may share IPD when we finish this research

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Small Bowel Disease

Clinical Trials on magnetic steering

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in United Kingdom

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe