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Magnetic Steering Improves Small Bowel Capsule Endoscopy Completion Rate

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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

Tracking Information
First Submitted Date  ICMJE March 5, 2018
First Posted Date  ICMJE March 29, 2018
Last Update Posted Date May 3, 2018
Actual Study Start Date  ICMJE June 1, 2017
Actual Primary Completion Date November 30, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 1, 2018)
CECR [ Time Frame: Two weeks ]
Capsule endoscopy completion rate
Original Primary Outcome Measures  ICMJE
 (submitted: March 28, 2018)
CECR [ Time Frame: 3 month ]
Capsule endoscopy completion rate
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 1, 2018)
  • Diagnostic cases by MCE [ Time Frame: Two weeks ]
    Esophageal, gastric, small bowel and colon diseases diagnosed by MCE
  • Transit time [ Time Frame: Two weeks ]
    Esophageal/gastric/pyloric/small bowel/total transit time
  • Rapid gastric transit rate [ Time Frame: Two weeks ]
    Rate of patients with a gastric transit time of ≤ 30 min
Original Secondary Outcome Measures  ICMJE
 (submitted: March 28, 2018)
  • Diagnostic yield by MCE [ Time Frame: 3 month ]
    gastric and small bowel diseases diagnosed by MCE
  • Transit time [ Time Frame: 3 month ]
    Esophageal/gastric/pyloric/total transit time
  • The gastric transit rate [ Time Frame: 3 month ]
    rate of patients with GTT ≤ 30 min
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Magnetic Steering Improves Small Bowel Capsule Endoscopy Completion Rate
Official Title  ICMJE Magnetic Steering of Capsule Endoscopy Improves Small Bowel Capsule Endoscopy Completion Rate
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Other
Condition  ICMJE
  • Capsule Endoscopy
  • Small Bowel Disease
Intervention  ICMJE Other: magnetic steering
The capsule was controlled to pass through the pylorus by magnet steering.
Study Arms  ICMJE
  • 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.
    Intervention: Other: magnetic steering
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 28, 2018)
227
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 30, 2017
Actual Primary Completion Date November 30, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03482661
Other Study ID Numbers  ICMJE MCE-CECR
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Plan Description: We may share IPD when we finish this research
Responsible Party Zhuan Liao, Changhai Hospital
Study Sponsor  ICMJE Zhuan Liao
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Changhai Hospital
Verification Date May 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP