Study of the Feasibility of Magnetic Navigated Capsule Endoscope in the Upper Gastrointestinal Tract Examination

NCT ID: NCT02886338

Last Updated: 2018-02-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-30
• Study Completion Date: 2016-11-30

Brief Summary

External control of capsule endoscopy (CE) by means of an applied magnetic field is a possible way to maneuver the movement of CE in gastrointestinal (GI) tract. The aim of this study was to evaluate the safety and feasibility of magnetic maneuvering of a capsule endoscope in the upper gastrointestinal tract, including the esophagus, stomach and duodenum in healthy subjects.

Detailed Description

Since their introduction in clinical practice in 2000, capsule endoscopy (CE) have widely used as a noninvasive endoscopic examination of the gastrointestinal disorders. Compared with traditional endoscopy, CE has had a significant impact in gastroenterology for diagnoses of gastrointestinal (GI) diseases, largely owing to the following three reasons. First, wireless CE is much more comfortable for the patient. Second, it is much easier and safer to perform. Third, it allows visualization of anatomical regions currently precluded to traditional endoscopy. However, CE does not allow the operator to control the navigation. The movement of the capsule is passive, as it proceeds by means of visceral peristalsis and gravity. This makes the movement of the capsule purely random, so that some portions of the gastrointestinal surface are unable to be visualized. Moreover, if gastrointestinal lesions are identified, the endoscopist cannot maneuver the capsule to perform back and forth, or right and left movement to do further detailed observations. All of these factors contribute to limit the diagnostic values of CE examination.

External controllability of CE by means of an applied magnetic field is a possible solution to the maneuvering problem. However, there is no effective system with straightforward clinical applicability till now. This is ascribable to a lack of reliable magnetic instrumentation suitable for such a purpose. We have reported that using magnetic field navigator can effectively control the locomotion of CE. We have demonstrated, both in vitro and ex vivo, that magnetic field navigator has great potential and practicability of achieving high-precision rotation and controllable movement of CE.

The aim of this study was to evaluate the safety and feasibility of magnetic maneuvering of a capsule endoscope in the upper gastrointestinal tract, including the esophagus, stomach and duodenum in healthy subjects. The movement of the endoscopic capsule in the esophagus could be driven by an external magnetic control device. The external magnetic control device could also adjust the direction of movement of the capsule in the stomach and duodenum, which might make the examination of the whole upper gastrointestinal tract possible. The magnetic navigated CE would enable detailed investigations of the whole upper gastrointestinal tract, including the esophagus, stomach and duodenum. Using this remote magnetic manipulation, capsule endoscope might improve diagnostic accuracy and extend the examination of specific area of interest in the gastrointestinal tract.

Conditions

Healthy Patient on Good Condition

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

capsule endoscopy examination

Capsule endoscopic examination for the esophagus, stomach and duodenum.

Group Type: EXPERIMENTAL

capsule endoscopy

Intervention Type: DEVICE

The magnetic navigated CE would enable detailed investigations of the whole upper gastrointestinal tract, including the esophagus, stomach and duodenum. Using this remote magnetic manipulation, capsule endoscope might improve diagnostic accuracy and extend the examination of specific area of interest in the gastrointestinal tract.

Interventions

capsule endoscopy

The magnetic navigated CE would enable detailed investigations of the whole upper gastrointestinal tract, including the esophagus, stomach and duodenum. Using this remote magnetic manipulation, capsule endoscope might improve diagnostic accuracy and extend the examination of specific area of interest in the gastrointestinal tract.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Aged 20-65 adults had experience on insudative upper endoscopy without any contraindication.

Exclusion Criteria

1. Patient with obstruction of gastrointestinal tract.

2. Pregnant woman.

3. Patient implantation of pacemaker.

4. Patient implanted with metal electronic devices、artificial joints or fixator.

5. Patient with cancer.

6. Patient with difficulty in swallowing.

7. Patient with operation on the stomach.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Taipei Medical University WanFang Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Fat Moon Suk

Role: STUDY_DIRECTOR

Taipei Medical University WanFang Hospital

Locations

Taipei Medical University - WanFang Hospital

Taipei, , Taiwan

Countries

Taiwan

Other Identifiers

201505067

Identifier Type: -

Identifier Source: org_study_id