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Magnetic Steering Improves Small Bowel Capsule Endoscopy Completion Rate

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03482661
Recruitment Status : Completed
First Posted : March 29, 2018
Last Update Posted : May 3, 2018
Sponsor:
Information provided by (Responsible Party):
Zhuan Liao, Changhai Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Capsule Endoscopy Small Bowel Disease Other: magnetic steering Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 227 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Other
Official Title: Magnetic Steering of Capsule Endoscopy Improves Small Bowel Capsule Endoscopy Completion Rate
Actual Study Start Date : June 1, 2017
Actual Primary Completion Date : November 30, 2017
Actual Study Completion Date : November 30, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy

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.




Primary Outcome Measures :
  1. CECR [ Time Frame: Two weeks ]
    Capsule endoscopy completion rate


Secondary Outcome Measures :
  1. Diagnostic cases by MCE [ Time Frame: Two weeks ]
    Esophageal, gastric, small bowel and colon diseases diagnosed by MCE

  2. Transit time [ Time Frame: Two weeks ]
    Esophageal/gastric/pyloric/small bowel/total transit time

  3. Rapid gastric transit rate [ Time Frame: Two weeks ]
    Rate of patients with a gastric transit time of ≤ 30 min



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03482661


Locations
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China
Shanghai Changhai Hospital
Shanghai, China
Sponsors and Collaborators
Zhuan Liao

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Zhuan Liao, professor, Changhai Hospital
ClinicalTrials.gov Identifier: NCT03482661    
Other Study ID Numbers: MCE-CECR
First Posted: March 29, 2018    Key Record Dates
Last Update Posted: May 3, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: We may share IPD when we finish this research

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Zhuan Liao, Changhai Hospital:
Magnetic steering
MCE
CECR
Additional relevant MeSH terms:
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Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases