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Completed

NCT Number: NCT03482661

Magnetic Steering 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.

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Key information

Conditions

Capsule Endoscopy Small Bowel Disease

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shanghai Changhai Hospital

Shanghai, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

magnetic steering

Other

The capsule was controlled to pass through the pylorus by magnet steering.

Primary outcomes

  1. CECR

    Time frame: Two weeks

    Capsule endoscopy completion rate

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Zhuan Liao

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Mar 29, 2018
Registry last updated
May 3, 2018

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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