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Magnetic Steering Improves Small Bowel Capsule Endoscopy Completion Rate

Primary Purpose

Capsule Endoscopy, Small Bowel Disease

Status

Completed

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

magnetic steering

About this trial

This is an interventional other trial for Capsule Endoscopy focused on measuring Magnetic steering, MCE, CECR

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Shanghai Changhai Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

Magnetic steering

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

CECR

Capsule endoscopy completion rate

Secondary Outcome Measures

Diagnostic cases by MCE

Esophageal, gastric, small bowel and colon diseases diagnosed by MCE

Transit time

Esophageal/gastric/pyloric/small bowel/total transit time

Rapid gastric transit rate

Rate of patients with a gastric transit time of ≤ 30 min

Full Information

NCT ID

NCT03482661

First Posted

March 5, 2018

Last Updated

May 1, 2018

Sponsor

Zhuan Liao

1. Study Identification

Unique Protocol Identification Number

NCT03482661

Brief Title

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

2. Study Status

Record Verification Date

May 2018

Overall Recruitment Status

Completed

Study Start Date

June 1, 2017 (Actual)

Primary Completion Date

November 30, 2017 (Actual)

Study Completion Date

November 30, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Zhuan Liao

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Capsule Endoscopy, Small Bowel Disease

Keywords

Magnetic steering, MCE, CECR

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Non-Randomized

Enrollment

227 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Control

Arm Type

No Intervention

Arm Description

Arm Title

Magnetic steering

Arm Type

Experimental

Arm Description

Intervention Type

Other

Intervention Name(s)

magnetic steering

Intervention Description

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

Primary Outcome Measure Information:

Title

CECR

Description

Capsule endoscopy completion rate

Time Frame

Two weeks

Secondary Outcome Measure Information:

Title

Diagnostic cases by MCE

Description

Esophageal, gastric, small bowel and colon diseases diagnosed by MCE

Time Frame

Two weeks

Title

Transit time

Description

Esophageal/gastric/pyloric/small bowel/total transit time

Time Frame

Two weeks

Title

Rapid gastric transit rate

Description

Rate of patients with a gastric transit time of ≤ 30 min

Time Frame

Two weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Facility Information:

Facility Name

Shanghai Changhai Hospital

City

Shanghai

Country

China

12. IPD Sharing Statement

Plan to Share IPD

Undecided

IPD Sharing Plan Description

We may share IPD when we finish this research

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