Magnetic Steering Enhance Capsule Gastroscopy Gastric Emptying

February 15, 2018 updated by: Zhuan Liao

New Method: Can Magnetic Steering Enhance Capsule Gastroscopy Gastric Emptying?

The research continuously enrolled 100 patients undergone MCCG between May to December 2017 as the intervention group with magnetic steering of capsule in the pylorus and duodenum, and randomly selected 100 patients before May 2017 from the database as the control group with passive movement of the capsule. The difference of the pyloric transit time (PTT) and duodenal papilla detection rate (DPDR) between the two groups were compared, and related factors were also investigated.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Background and Aims: Capsule endoscopy is a valuable tool in the diagnosis of small bowel disease. However, the incompletion of small bowel examination may reduce the diagnostic accuracy, which mainly caused by delayed capsule gastric emptying. Thus the aim of this study was to validate the effect of magnetic steering on enhancing gastric emptying and mucosal visualization within duodenum during magnetically controlled capsule gastroscopy (MCCG) examination.

Methods: As a historical prospective cohort study, the research continuously enrolled 100 patients undergone MCCG between May to December 2017 as the intervention group with magnetic steering of capsule in the pylorus and duodenum, and randomly selected 100 patients before May 2017 from the database as the control group with passive movement of the capsule. The difference of the pyloric transit time (PTT) and duodenal papilla detection rate (DPDR) between the two groups were compared, and related factors were also investigated.

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

1. patients over 18 years of age undergone MCCG examination in Changhai Hospital

Exclusion Criteria:

  1. pregnancy or suspected pregnancy;
  2. suspected or known intestinal stenosis;
  3. pacemaker, other implanted electro medical devices which could interfere with magnetic resonance; (4) undergone a known surgery which could possibly affect visualization of the duodenal papilla;

(5) other conditions which may lead to capsule retention.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: control
The patients swallowed the capsule with water in the lying position.After finishing the stomach examination, the operation of the capsule is adjusted to "small bowel mode" without magnetic control. Capsule entered the duodenum under physiological peristalsis. The position of the capsule was established using a real-time viewer. If the capsule failed to enter the duodenum after one hour, domperidone (10 mg) was orally administered.
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. After reaching the duodenal bulb, capsule was held to the maximum position of "Z", then the capsule would scan the duodenal bulb automatically with the mode "360° automatic scanning".
Other: magnetic steering
magnetic steering

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PTT
Time Frame: 3 month
pyloric transit time
3 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
DPDR
Time Frame: 3 month
duodenal papilla detection rate
3 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zhuan Liao

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2017

Primary Completion (Anticipated)

February 28, 2018

Study Completion (Anticipated)

February 28, 2018

Study Registration Dates

First Submitted

February 8, 2018

First Submitted That Met QC Criteria

February 15, 2018

First Posted (Actual)

February 22, 2018

Study Record Updates

Last Update Posted (Actual)

February 22, 2018

Last Update Submitted That Met QC Criteria

February 15, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • MS-enhance-MCCG-GE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

We may share IPD when we finish this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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