Clinical trial NCT03482661: Magnetic Steering Improves Small Bowel Capsule Endoscopy Completion Rate
Official title: Magnetic Steering of Capsule Endoscopy Improves Small Bowel Capsule Endoscopy Completion Rate
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Capsule Endoscopy
Small Bowel Disease
Keywords: Magnetic steering
MCE
CECR
Lead sponsor: Changhai Hospital
Sponsor class: OTHER
First posted: 2018-03-29
Enrollment: 227
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility 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

Primary outcomes:
measure: CECR
timeFrame: Two weeks
Secondary outcomes:
measure: Diagnostic cases by MCE
timeFrame: Two weeks
measure: Transit time
timeFrame: Two weeks
measure: Rapid gastric transit rate
timeFrame: Two weeks
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Changhai Hospital
Study officials:
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