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
|Condition or disease||Intervention/treatment||Phase|
|Capsule Endoscopy Small Bowel Disease||Other: magnetic steering||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||227 participants|
|Intervention Model:||Parallel Assignment|
|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|
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.
- CECR [ Time Frame: Two weeks ]Capsule endoscopy completion rate
- 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
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
|Shanghai Changhai Hospital|